Healthy VolunteersPhase 1NCT07629999
Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants
A Phase 1 study testing BMS-986533, Famotidine and Dabigatran Etexilate in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986533, Famotidine and Dabigatran Etexilate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg.
- Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.
- A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.
Who cannot join
- Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).
- Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
- Participants must not have any major surgery within 3 months of study intervention administration.
- Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).
- Other protocol defined inclusion/exclusion criteria applies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
Celerion Coorporate Office Nebraska
Lincoln, Nebraska, 68502
Allen Hunt, Site 0001
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986533, Famotidine, Placebo, Dabigatran Etexilate, Rosuvastatin
- Keywords
- Healthy, BMS-986533, Food effect, pH effect, rBA, DDI, Dabigatran, Rosuvastatin, Fasted, Fed, Single ascending dose, Multiple ascending dose
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986533Drug
Specified dose on specified days
FamotidineDrug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
Dabigatran EtexilateDrug
Specified dose on specified days
RosuvastatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: BMS-986533; Drug: Placebo |
| Arm B | Experimental | Not described Receives: Drug: BMS-986533; Drug: Placebo |
| Arm C | Experimental | Not described Receives: Drug: BMS-986533; Drug: Famotidine |
| Arm D | Experimental | Not described Receives: Drug: BMS-986533; Drug: Dabigatran Etexilate; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AE)
Measured: Up to Day 47
Number of participants with Serious Adverse Events (SAE)
Measured: Up to Day 47
Number of participants with Vital Sign Abnormalities
Measured: Up to Day 27
Number of participants with Physical Examination Abnormalities
Including neurological examination
Measured: Up to Day 27
Number of participants with Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 27
Number of participants with Clinical Laboratory Assessments Abnormalities
Measured: Up to Day 27
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 27
Secondary outcomes (28)
Maximum observed concentration (Cmax)
Measured: Up to Day 26 from last dose
Time of maximum observed concentration (Tmax)
Measured: Up to Day 26 from last dose
Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Arm A, Arm B, and Arm C
Measured: Up to Day 26 from last dose
AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))
Arm A and Arm C
Measured: Up to Day 26 from last dose
AUC from Time Zero to 24 Hours (AUC(0-24))
Arm A
Measured: Up to Day 9 from last dose
Elimination Half-Life (T-HALF)
Arm A, Arm B, and Arm C
Measured: Up to Day 26 from last dose
Apparent Total Body Clearance from Plasma (CLT/F)
Arm A, Arm B, and Arm C
Measured: Up to Day 26 from last dose
Apparent Volume of Distribution (Vz/F)
Arm A, Arm B, and Arm C
Measured: Up to Day 26 from last dose
AUC in 1 dosing interval (AUC (TAU))
Arm B, D
Measured: Up to Day 22 from last dose
Cerebrospinal fluid (CSF) concentrations
Arm B
Measured: Up to Day 13
Ratio of total and unbound CSF to plasma concentration
Arm B
Measured: Up to Day 13
Geometric mean ratio of Cmax
Arm C, D
Measured: Up to Day 26 from last dose
Geometric mean ratio of AUC(0-T)
Arm C, D
Measured: Up to Day 26 from last dose
Geometric mean ratio of AUC(INF)
Arm C, D
Measured: Up to Day 26 from last dose
Cmax of dabigatran in plasma
Arm D
Measured: Up to Day 18 from last dose
Cmax of rosuvastatin in plasma
Arm D
Measured: Up to Day 20 from last dose
AUC(0-T) of dabigatran in plasma
Arm D
Measured: Up to Day 18 from last dose
AUC(0-T) of rosuvastatin in plasma
Arm D
Measured: Up to Day 20 from last dose
AUC(INF) of dabigatran in plasma
Arm D
Measured: Up to Day 18 from last dose
AUC(INF) of rosuvastatin in plasma
Arm D
Measured: Up to Day 20 from last dose
Tmax of dabigatran in plasma
Arm D
Measured: Up to Day 18 from last dose
Tmax of rosuvastatin in plasma
Arm D
Measured: Up to Day 20 from last dose
T-HALF of dabigatran in plasma
Measured: Up to Day 26 from last dose
T-HALF of rosuvastatin in plasma
Arm D
Measured: Up to Day 20 from last dose
CLT/F of dabigatran in plasma
Arm D
Measured: Up to Day 18 from last dose
CLT/F of rosuvastatin in plasma
Measured: Up to Day 27 from last dose
Vz/F of dabigatran in plasma
Arm D
Measured: Up to Day 18 from last dose
Vz/F of rosuvastatin in plasma
Arm D
Measured: Up to Day 20 from last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start13 Jul 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629999
- Sponsor's protocol ID
- CN016-0001
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07629999
- Acronym / sponsor ID
- CN016-0001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy, BMS-986533, Food effect, pH effect, rBA, DDI, Dabigatran, Rosuvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Jun 2026 (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 safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BMS-986533, Drug: Placebo |
| Arm B | Experimental | Drug: BMS-986533, Drug: Placebo |
| Arm C | Experimental | Drug: BMS-986533, Drug: Famotidine |
| Arm D | Experimental | Drug: BMS-986533, Drug: Dabigatran Etexilate, Drug: Rosuvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg.
- Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.
- A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.
Key exclusion criteria (5 listed)
- Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).
- Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
- Participants must not have any major surgery within 3 months of study intervention administration.
- Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).
- Other protocol defined inclusion/exclusion criteria applies.
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 |
|---|---|---|
| BMS-986533Specified dose on specified days | Drug | Arm A, Arm B, Arm C, Arm D |
| FamotidineSpecified dose on specified days | Drug | Arm C |
| PlaceboSpecified dose on specified days | Drug | Arm A, Arm B |
| Dabigatran EtexilateSpecified dose on specified days | Drug | Arm D |
| RosuvastatinSpecified dose on specified days | Drug | Arm D |
Primary outcome
Number of participants with Adverse Events (AE)
Time frame: Up to Day 47
Number of participants with Serious Adverse Events (SAE)
Time frame: Up to Day 47
Number of participants with Vital Sign Abnormalities
Time frame: Up to Day 27
Number of participants with Physical Examination Abnormalities
Time frame: Up to Day 27
Including neurological examination
Number of participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 27
Number of participants with Clinical Laboratory Assessments Abnormalities
Time frame: Up to Day 27
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 27
28 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to Day 26 from last dose
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 26 from last dose
Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Time frame: Up to Day 26 from last dose
AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))
Time frame: Up to Day 26 from last dose
AUC from Time Zero to 24 Hours (AUC(0-24))
Time frame: Up to Day 9 from last dose
Elimination Half-Life (T-HALF)
Time frame: Up to Day 26 from last dose
Apparent Total Body Clearance from Plasma (CLT/F)
Time frame: Up to Day 26 from last dose
Apparent Volume of Distribution (Vz/F)
Time frame: Up to Day 26 from last dose
AUC in 1 dosing interval (AUC (TAU))
Time frame: Up to Day 22 from last dose
Cerebrospinal fluid (CSF) concentrations
Time frame: Up to Day 13
Ratio of total and unbound CSF to plasma concentration
Time frame: Up to Day 13
Geometric mean ratio of Cmax
Time frame: Up to Day 26 from last dose
Geometric mean ratio of AUC(0-T)
Time frame: Up to Day 26 from last dose
Geometric mean ratio of AUC(INF)
Time frame: Up to Day 26 from last dose
Cmax of dabigatran in plasma
Time frame: Up to Day 18 from last dose
Cmax of rosuvastatin in plasma
Time frame: Up to Day 20 from last dose
AUC(0-T) of dabigatran in plasma
Time frame: Up to Day 18 from last dose
AUC(0-T) of rosuvastatin in plasma
Time frame: Up to Day 20 from last dose
AUC(INF) of dabigatran in plasma
Time frame: Up to Day 18 from last dose
AUC(INF) of rosuvastatin in plasma
Time frame: Up to Day 20 from last dose
Tmax of dabigatran in plasma
Time frame: Up to Day 18 from last dose
Tmax of rosuvastatin in plasma
Time frame: Up to Day 20 from last dose
T-HALF of dabigatran in plasma
Time frame: Up to Day 26 from last dose
T-HALF of rosuvastatin in plasma
Time frame: Up to Day 20 from last dose
CLT/F of dabigatran in plasma
Time frame: Up to Day 18 from last dose
CLT/F of rosuvastatin in plasma
Time frame: Up to Day 27 from last dose
Vz/F of dabigatran in plasma
Time frame: Up to Day 18 from last dose
Vz/F of rosuvastatin in plasma
Time frame: Up to Day 20 from last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Related trials for Healthy Volunteers
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-986533, Famotidine and Dabigatran Etexilate in people with Healthy Volunteers, run by Bristol-Myers Squibb 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AE) (time frame: Up to Day 47). The study lists 7 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 24 Jul 2026.