HealthyPhase 1NCT04844424
A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants
A Phase 1 study testing Milvexian in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules (Part 1) and of new concept tablets consisting of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Milvexian
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 12 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
- Body mass index (BMI equals to [=] weight/height^2) between 18 and 30 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg at screening
- Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Treatment Period 1. If the results of the safety laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant except as specified in Exclusion Criteria 2. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day 1 of Treatment Period 1
- Before randomization, a woman must be either: a) Not of childbearing potential defined as: postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level greater than (>) 40 international units per liter IU/L or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal replacement therapy (HRT), however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; b) Of childbearing potential and; practicing a highly effective method of contraception (failure rate of less than [<] 1 percent [%] per year when used consistently and correctly) for at least 3 months prior to the study entry and; agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
- During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/ film/cream/suppository)
Who cannot join
- History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol-specified assessments. This may include but is not limited to any known bleeding or clotting disorder, a history of arterial or venous thrombosis, liver or renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplasm, metabolic disturbances, or poor venous access
- Clinically significant abnormal values for hematology, coagulation, clinical chemistry, or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee. Any of the following laboratory results outside of the normal ranges specified below at screening or Day -1 of Treatment Period 1 which must be confirmed by repeat: Hemoglobin or hematocrit less than (<) lower limit of normal; Platelet count < lower limit of normal; activated partial thromboplastin time (aPTT) or prothrombin time (PT) >1.2*upper limit of normal (ULN)
- Use of any agent, including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other anti-platelet agents, anticoagulants, fish oil capsules, ginkgo or any agent that can potentially increase the risk of bleeding within 14 days prior to the first dose of study drug administration
- History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
- History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
- Woman with history of excessive menstrual bleeding as determined by the investigator or appropriate designee
- Does not tolerate venipuncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Relative Oral Bioavailability, Pharmacokinetics, and Food Effect After Single Dose (for Part 1, Part 3, Part 4 and Part 5) or Multiple-Dose (for Part 2) Administration of JNJ-70033093 (Milvexian) in Healthy Adult Participants Using Tablet, Capsule and Dispersed Tablet Formulations
The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules (Part 1) and of new concept tablets consisting of a single dose of milvexian administered as oral Tablet 1 and Tablet 2 compared with milvexian administered as Phase 2 oral capsules (Part 3) in healthy participants under fasting and fed conditions; to characterize the pharmacokinetics (PK) of multiple twice daily (BID) doses for 5 days of milvexian administered as DC oral tablets and Phase 2 oral capsules in healthy participants (Part 2) and to assess the effects of dosing time and food timing on the PK of single-dose of milvexian Phase 3 oral tablet formulation in healthy participants (Part 4) and to evaluate the relative bioavailability of a single dose of milvexian administered as oral film-coated DC whole tablets, oral film-coated DC tablets dispersed in water and then mixed with apple sauce, and oral film-coated DC tablets dispersed in water and administered as a suspension using a nasogastric (NG) tube in healthy participants under fasting conditions (Part 5).
- Conditions
- Healthy
- Being tested
- Milvexian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilvexianDrug
Also called JNJ-70033093, BMS-986177
Milvexian will be administered orally or via nasogastric route as tablets or capsules.
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Treatment Sequence ABC | Experimental | Participants will receive a single oral Dose 1 of milvexian as direct compression (DC) tablets under fasting conditions (Treatment A) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as roller compacted (RC) tablets under fasting conditions (Treatment B) in Treatment Period 2 and then a single oral Dose 1 of milvexian Phase 2 oral capsules under fasting conditions (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1A: Treatment Sequence BCA | Experimental | Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1A: Treatment Sequence CAB | Experimental | Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1A: Treatment Sequence ACB | Experimental | Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1A: Treatment Sequence BAC | Experimental | Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1A: Treatment Sequence CBA | Experimental | Participants will receive Treatment C in Treatment Period 1 followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1B: Treatment Sequence DEF | Experimental | Participants will receive a single oral Dose 1 of milvexian as DC oral tablets under fed conditions (Treatment D) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as RC oral tablets under fed conditions (Treatment E) in Treatment Period 2 and then a single oral Dose 1 of milvexian as Phase 2 oral capsules under fed conditions (Treatment F) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1B: Treatment Sequence EFD | Experimental | Participants will receive Treatment E in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1B: Treatment Sequence FDE | Experimental | Participants will receive Treatment F in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1B: Treatment Sequence DFE | Experimental | Participants will receive Treatment D in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1B: Treatment Sequence EDF | Experimental | Participants will receive Treatment E in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment F in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 1B: Treatment Sequence FED | Experimental | Participants will receive Treatment F in Treatment Period 1, followed by Treatment E in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 2A: Treatment Sequence GH | Experimental | Participants will receive twice daily (BID) oral Dose 1 of milvexian DC oral tablets (Treatment G) in Treatment Period 1, followed by BID oral Dose 1 of milvexian Phase 2 oral capsule (Treatment H) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. Receives: Drug: Milvexian |
| Part 2A: Treatment Sequence HG | Experimental | Participants will receive Treatment H in Treatment Period 1, followed by Treatment G in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. Receives: Drug: Milvexian |
| Part 2B: Treatment Sequence IJ | Experimental | Participants will receive BID oral Dose 2 of milvexian DC oral tablet (Treatment I) in Treatment Period 1, followed by BID oral Dose 2 of milvexian Phase 2 oral capsule (Treatment J) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. Receives: Drug: Milvexian |
| Part 2B: Treatment Sequence JI | Experimental | Participants will receive Treatment J in Treatment Period 1, followed by Treatment I in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. Receives: Drug: Milvexian |
| Part 3A: Treatment Sequence KLM | Experimental | Participants will receive single oral Dose 1 of milvexian as oral Tablet 1 under fasting conditions (Treatment K) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fasting conditions (Treatment L) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 2 oral capsules under fasting conditions (Treatment M) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3A: Treatment Sequence LMK | Experimental | Participants will receive Treatment L in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 of each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3A: Treatment Sequence MKL | Experimental | Participants will receive Treatment M in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3A: Treatment Sequence KML | Experimental | Participants will receive Treatment K in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3A: Treatment Sequence LKM | Experimental | Participants will receive Treatment L in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment M in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3A: Treatment Sequence MLK | Experimental | Participants will receive Treatment M in Treatment Period 1, followed by Treatment L in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3B: Treatment Sequence NOP | Experimental | Participants will receive single oral Dose 1 of milvexian oral Tablet 1 under fed conditions (Treatment N) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fed conditions (Treatment O) in Treatment Period 2 and then single oral Dose 1 of milvexian Phase 2 oral capsule under fed conditions (Treatment P) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3B: Treatment Sequence OPN | Experimental | Participants will receive Treatment O in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3B: Treatment Sequence PNO | Experimental | Participants will receive Treatment P in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3B: Treatment Sequence NPO | Experimental | Participants will receive Treatment N in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3B: Treatment Sequence ONP | Experimental | Participants will receive Treatment O in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment P in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 3B: Treatment Sequence PON | Experimental | Participants will receive Treatment P in Treatment Period 1, followed by Treatment O in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4 A: Treatment Sequence QRS | Experimental | Participants will receive single oral Dose 1 of milvexian as Phase 3 oral tablets under fasting conditions (Treatment Q) in Treatment Period 1, followed by single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment R) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment S) in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4A: Treatment Sequence RSQ | Experimental | Participants will receive Treatment R in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4A: Treatment Sequence SQR | Experimental | Participants will receive Treatment S in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4A: Treatment Sequence QSR | Experimental | Participants will receive Treatment Q in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4A: Treatment Sequence RQS | Experimental | Participants will receive Treatment R in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment S in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4A: Treatment Sequence SRQ | Experimental | Participants will receive Treatment S in Treatment Period 1, followed by Treatment R in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4B: Treatment Sequence TU | Experimental | Participants will receive single oral Dose 1 of milvexian as Phase 3 oral tablet under fed conditions (Treatment T) in Treatment Period 1, followed by single oral Dose 2 of milvexian as Phase 3 oral tablet under fed conditions (Treatment U) in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 4B: Treatment Sequence UT | Experimental | Participants will receive Treatment U in Treatment Period 1, followed by Treatment T in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Subpart 4A: Treatment Sequence VW | Experimental | All participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive milvexian tablet dispersed in water without a sweetener orally via syringe (Treatment V) in Treatment Period 1, followed by milvexian tablet dispersed in water with sucralose sweetener orally via syringe (Treatment W) in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round. Receives: Drug: Milvexian |
| Subpart 4A: Treatment Sequence WV | Experimental | All participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive Treatment W in Treatment Period 1, followed by Treatment V in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round. Receives: Drug: Milvexian |
| Part 5: Treatment Sequence XYZ | Experimental | Participants will receive a single oral Dose 1 of milvexian as DC whole tablets under fasting conditions (Treatment X) in Treatment Period 1 followed by a single oral Dose 1 of milvexian as DC tablets dispersed in water and then mixed with apple sauce under fasting conditions (Treatment Y) in Treatment Period 2 and then a single oral Dose 1 of milvexian as DC tablets dispersed in water administered through a nasogastric (NG) tube under fasting conditions (Treatment Z) in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 5: Treatment Sequence YZX | Experimental | Participants will receive Treatment Y in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 5: Treatment Sequence ZXY | Experimental | Participants will receive Treatment Z in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 5: Treatment Sequence XZY | Experimental | Participants will receive Treatment X in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 5: Treatment Sequence YXZ | Experimental | Participants will receive Treatment Y in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Z in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
| Part 5: Treatment Sequence ZYX | Experimental | Participants will receive Treatment Z in Treatment Period 1 followed by Treatment Y in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. Receives: Drug: Milvexian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity])
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Measured: Up to 16 months
Part 2: Area under the Plasma Concentration-time Curve of Milvexian From Time Zero to Time of Last Quantifiable Concentration (AUC [0-Last])
AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.
Measured: Up to 16 months
Maximum Observed Analyte Concentration (Cmax) of Milvexian
Cmax is defined as maximum observed analyte concentration of milvexian.
Measured: Up to 16 months
Parts 1 and 3: AUC (0-Infinity) of Milvexian (Food effect)
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Measured: Up to 16 months
Parts 1 and 3: AUC (0-Last) of Milvexian (Food effect)
AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.
Measured: Up to 16 months
Parts 1 and 3: Cmax of Milvexian (Food effect)
Cmax is defined as maximum observed analyte concentration of milvexian.
Measured: Up to 16 months
Actual Sampling Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Milvexian
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Measured: Up to 16 months
Parts 1 and 3: Tmax of Milvexian (Food effect)
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Measured: Up to 16 months
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
14 Apr 202112 Jul 2022
- First posted14 Apr 2021
- Study start14 Apr 2021
- Primary completion6 May 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844424
- Sponsor's protocol ID
- CR108999
- Other IDs
- 70033093THR1008
- Status last verified
- May 2025
- First submitted
- 12 Apr 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Study to Evaluate the Relative Oral Bioavailability, Pharmacokinetics, and Food Effect After Single Dose (for Part 1, Part 3, Part 4 and Part 5) or Multiple-Dose (for Part 2) Administration of JNJ-70033093 (Milvexian) in Healthy Adult Participants Using Tablet, Capsule and Dispersed Tablet Formulations
- ClinicalTrials.gov ID
- NCT04844424
- Acronym / sponsor ID
- CR108999
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules (Part 1) and of new concept tablets consisting of a single dose of milvexian administered as oral Tablet 1 and Tablet 2 compared with milvexian administered as Phase 2 oral capsules (Part 3) in healthy participants under fasting and fed conditions; to characterize the pharmacokinetics (PK) of multiple twice daily (BID) doses for 5 days of milvexian administered as DC oral tablets and Phase 2 oral capsules in healthy participants (Part 2) and to assess the effects of dosing time and food timing on the PK of single-dose of milvexian Phase 3 oral tablet formulation in healthy participants (Part 4) and to evaluate the relative bioavailability of a single dose of milvexian administered as oral film-coated DC whole tablets, oral film-coated DC tablets dispersed in water and then mixed with apple sauce, and oral film-coated DC tablets dispersed in water and administered as a suspension using a nasogastric (NG) tube in healthy participants under fasting conditions (Part 5).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 44
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Treatment Sequence ABC | Experimental | Drug: MilvexianParticipants will receive a single oral Dose 1 of milvexian as direct compression (DC) tablets under fasting conditions (Treatment A) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as roller compacted (RC) tablets under fasting conditions (Treatment B) in Treatment Period 2 and then a single oral Dose 1 of milvexian Phase 2 oral capsules under fasting conditions (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1A: Treatment Sequence BCA | Experimental | Drug: MilvexianParticipants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1A: Treatment Sequence CAB | Experimental | Drug: MilvexianParticipants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1A: Treatment Sequence ACB | Experimental | Drug: MilvexianParticipants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1A: Treatment Sequence BAC | Experimental | Drug: MilvexianParticipants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1A: Treatment Sequence CBA | Experimental | Drug: MilvexianParticipants will receive Treatment C in Treatment Period 1 followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1B: Treatment Sequence DEF | Experimental | Drug: MilvexianParticipants will receive a single oral Dose 1 of milvexian as DC oral tablets under fed conditions (Treatment D) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as RC oral tablets under fed conditions (Treatment E) in Treatment Period 2 and then a single oral Dose 1 of milvexian as Phase 2 oral capsules under fed conditions (Treatment F) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1B: Treatment Sequence EFD | Experimental | Drug: MilvexianParticipants will receive Treatment E in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1B: Treatment Sequence FDE | Experimental | Drug: MilvexianParticipants will receive Treatment F in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1B: Treatment Sequence DFE | Experimental | Drug: MilvexianParticipants will receive Treatment D in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1B: Treatment Sequence EDF | Experimental | Drug: MilvexianParticipants will receive Treatment E in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment F in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 1B: Treatment Sequence FED | Experimental | Drug: MilvexianParticipants will receive Treatment F in Treatment Period 1, followed by Treatment E in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 2A: Treatment Sequence GH | Experimental | Drug: MilvexianParticipants will receive twice daily (BID) oral Dose 1 of milvexian DC oral tablets (Treatment G) in Treatment Period 1, followed by BID oral Dose 1 of milvexian Phase 2 oral capsule (Treatment H) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. |
| Part 2A: Treatment Sequence HG | Experimental | Drug: MilvexianParticipants will receive Treatment H in Treatment Period 1, followed by Treatment G in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. |
| Part 2B: Treatment Sequence IJ | Experimental | Drug: MilvexianParticipants will receive BID oral Dose 2 of milvexian DC oral tablet (Treatment I) in Treatment Period 1, followed by BID oral Dose 2 of milvexian Phase 2 oral capsule (Treatment J) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. |
| Part 2B: Treatment Sequence JI | Experimental | Drug: MilvexianParticipants will receive Treatment J in Treatment Period 1, followed by Treatment I in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2. |
| Part 3A: Treatment Sequence KLM | Experimental | Drug: MilvexianParticipants will receive single oral Dose 1 of milvexian as oral Tablet 1 under fasting conditions (Treatment K) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fasting conditions (Treatment L) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 2 oral capsules under fasting conditions (Treatment M) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3A: Treatment Sequence LMK | Experimental | Drug: MilvexianParticipants will receive Treatment L in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 of each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3A: Treatment Sequence MKL | Experimental | Drug: MilvexianParticipants will receive Treatment M in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3A: Treatment Sequence KML | Experimental | Drug: MilvexianParticipants will receive Treatment K in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3A: Treatment Sequence LKM | Experimental | Drug: MilvexianParticipants will receive Treatment L in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment M in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3A: Treatment Sequence MLK | Experimental | Drug: MilvexianParticipants will receive Treatment M in Treatment Period 1, followed by Treatment L in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3B: Treatment Sequence NOP | Experimental | Drug: MilvexianParticipants will receive single oral Dose 1 of milvexian oral Tablet 1 under fed conditions (Treatment N) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fed conditions (Treatment O) in Treatment Period 2 and then single oral Dose 1 of milvexian Phase 2 oral capsule under fed conditions (Treatment P) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3B: Treatment Sequence OPN | Experimental | Drug: MilvexianParticipants will receive Treatment O in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3B: Treatment Sequence PNO | Experimental | Drug: MilvexianParticipants will receive Treatment P in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3B: Treatment Sequence NPO | Experimental | Drug: MilvexianParticipants will receive Treatment N in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3B: Treatment Sequence ONP | Experimental | Drug: MilvexianParticipants will receive Treatment O in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment P in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 3B: Treatment Sequence PON | Experimental | Drug: MilvexianParticipants will receive Treatment P in Treatment Period 1, followed by Treatment O in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4 A: Treatment Sequence QRS | Experimental | Drug: MilvexianParticipants will receive single oral Dose 1 of milvexian as Phase 3 oral tablets under fasting conditions (Treatment Q) in Treatment Period 1, followed by single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment R) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment S) in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4A: Treatment Sequence RSQ | Experimental | Drug: MilvexianParticipants will receive Treatment R in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4A: Treatment Sequence SQR | Experimental | Drug: MilvexianParticipants will receive Treatment S in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4A: Treatment Sequence QSR | Experimental | Drug: MilvexianParticipants will receive Treatment Q in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4A: Treatment Sequence RQS | Experimental | Drug: MilvexianParticipants will receive Treatment R in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment S in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4A: Treatment Sequence SRQ | Experimental | Drug: MilvexianParticipants will receive Treatment S in Treatment Period 1, followed by Treatment R in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4B: Treatment Sequence TU | Experimental | Drug: MilvexianParticipants will receive single oral Dose 1 of milvexian as Phase 3 oral tablet under fed conditions (Treatment T) in Treatment Period 1, followed by single oral Dose 2 of milvexian as Phase 3 oral tablet under fed conditions (Treatment U) in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 4B: Treatment Sequence UT | Experimental | Drug: MilvexianParticipants will receive Treatment U in Treatment Period 1, followed by Treatment T in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Subpart 4A: Treatment Sequence VW | Experimental | Drug: MilvexianAll participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive milvexian tablet dispersed in water without a sweetener orally via syringe (Treatment V) in Treatment Period 1, followed by milvexian tablet dispersed in water with sucralose sweetener orally via syringe (Treatment W) in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round. |
| Subpart 4A: Treatment Sequence WV | Experimental | Drug: MilvexianAll participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive Treatment W in Treatment Period 1, followed by Treatment V in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round. |
| Part 5: Treatment Sequence XYZ | Experimental | Drug: MilvexianParticipants will receive a single oral Dose 1 of milvexian as DC whole tablets under fasting conditions (Treatment X) in Treatment Period 1 followed by a single oral Dose 1 of milvexian as DC tablets dispersed in water and then mixed with apple sauce under fasting conditions (Treatment Y) in Treatment Period 2 and then a single oral Dose 1 of milvexian as DC tablets dispersed in water administered through a nasogastric (NG) tube under fasting conditions (Treatment Z) in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 5: Treatment Sequence YZX | Experimental | Drug: MilvexianParticipants will receive Treatment Y in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 5: Treatment Sequence ZXY | Experimental | Drug: MilvexianParticipants will receive Treatment Z in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 5: Treatment Sequence XZY | Experimental | Drug: MilvexianParticipants will receive Treatment X in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 5: Treatment Sequence YXZ | Experimental | Drug: MilvexianParticipants will receive Treatment Y in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Z in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
| Part 5: Treatment Sequence ZYX | Experimental | Drug: MilvexianParticipants will receive Treatment Z in Treatment Period 1 followed by Treatment Y in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
- Body mass index (BMI equals to [=] weight/height^2) between 18 and 30 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg at screening
- Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Treatment Period 1. If the results of the safety laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant except as specified in Exclusion Criteria 2. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day 1 of Treatment Period 1
- Before randomization, a woman must be either: a) Not of childbearing potential defined as: postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level greater than (>) 40 international units per liter IU/L or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal replacement therapy (HRT), however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; b) Of childbearing potential and; practicing a highly effective method of contraception (failure rate of less than [<] 1 percent [%] per year when used consistently and correctly) for at least 3 months prior to the study entry and; agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
Key exclusion criteria (7 listed)
- History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol-specified assessments. This may include but is not limited to any known bleeding or clotting disorder, a history of arterial or venous thrombosis, liver or renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplasm, metabolic disturbances, or poor venous access
- Clinically significant abnormal values for hematology, coagulation, clinical chemistry, or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee. Any of the following laboratory results outside of the normal ranges specified below at screening or Day -1 of Treatment Period 1 which must be confirmed by repeat: Hemoglobin or hematocrit less than (<) lower limit of normal; Platelet count < lower limit of normal; activated partial thromboplastin time (aPTT) or prothrombin time (PT) >1.2*upper limit of normal (ULN)
- Use of any agent, including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other anti-platelet agents, anticoagulants, fish oil capsules, ginkgo or any agent that can potentially increase the risk of bleeding within 14 days prior to the first dose of study drug administration
- History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
- History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilvexianAlso: JNJ-70033093, BMS-986177Milvexian will be administered orally or via nasogastric route as tablets or capsules. | Drug | Part 1A: Treatment Sequence ABC, Part 1A: Treatment Sequence ACB, Part 1A: Treatment Sequence BAC, Part 1A: Treatment Sequence BCA, Part 1A: Treatment Sequence CAB, Part 1A: Treatment Sequence CBA, Part 1B: Treatment Sequence DEF, Part 1B: Treatment Sequence DFE, Part 1B: Treatment Sequence EDF, Part 1B: Treatment Sequence EFD, Part 1B: Treatment Sequence FDE, Part 1B: Treatment Sequence FED, Part 2A: Treatment Sequence GH, Part 2A: Treatment Sequence HG, Part 2B: Treatment Sequence IJ, Part 2B: Treatment Sequence JI, Part 3A: Treatment Sequence KLM, Part 3A: Treatment Sequence KML, Part 3A: Treatment Sequence LKM, Part 3A: Treatment Sequence LMK, Part 3A: Treatment Sequence MKL, Part 3A: Treatment Sequence MLK, Part 3B: Treatment Sequence NOP, Part 3B: Treatment Sequence NPO, Part 3B: Treatment Sequence ONP, Part 3B: Treatment Sequence OPN, Part 3B: Treatment Sequence PNO, Part 3B: Treatment Sequence PON, Part 4 A: Treatment Sequence QRS, Part 4A: Treatment Sequence QSR, Part 4A: Treatment Sequence RQS, Part 4A: Treatment Sequence RSQ, Part 4A: Treatment Sequence SQR, Part 4A: Treatment Sequence SRQ, Part 4B: Treatment Sequence TU, Part 4B: Treatment Sequence UT, Part 5: Treatment Sequence XYZ, Part 5: Treatment Sequence XZY, Part 5: Treatment Sequence YXZ, Part 5: Treatment Sequence YZX, Part 5: Treatment Sequence ZXY, Part 5: Treatment Sequence ZYX, Subpart 4A: Treatment Sequence VW, Subpart 4A: Treatment Sequence WV |
Primary outcome
Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity])
Time frame: Up to 16 months
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Part 2: Area under the Plasma Concentration-time Curve of Milvexian From Time Zero to Time of Last Quantifiable Concentration (AUC [0-Last])
Time frame: Up to 16 months
AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.
Maximum Observed Analyte Concentration (Cmax) of Milvexian
Time frame: Up to 16 months
Cmax is defined as maximum observed analyte concentration of milvexian.
Parts 1 and 3: AUC (0-Infinity) of Milvexian (Food effect)
Time frame: Up to 16 months
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Parts 1 and 3: AUC (0-Last) of Milvexian (Food effect)
Time frame: Up to 16 months
AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.
Parts 1 and 3: Cmax of Milvexian (Food effect)
Time frame: Up to 16 months
Cmax is defined as maximum observed analyte concentration of milvexian.
Actual Sampling Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Milvexian
Time frame: Up to 16 months
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Parts 1 and 3: Tmax of Milvexian (Food effect)
Time frame: Up to 16 months
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
1 secondary outcome
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Milvexian in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity]) (time frame: Up to 16 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.