HealthyPhase 1NCT02466815

A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets

A Phase 1 study testing JNJ-42756493 Current Clinical Formulation (G-018), JNJ-42756493 Prototype Formulation I (G-025) and JNJ-42756493 Prototype Formulation II (G-025) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet. 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?: JNJ-42756493 Current Clinical Formulation (G-018), JNJ-42756493 Prototype Formulation I (G-025) and JNJ-42756493 Prototype Formulation II (G-025)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteBelgium
Study dates: Jun 2015to Aug 2015
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

Participants should be willing to adhere to the prohibitions and restrictions specified in this protocol
Woman must be either: postmenopausal (greater than (>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (follicle stimulating hormone [FSH]) >40 international unit per litre [IU/L]); surgically sterile
Woman must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug.
Man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Who cannot join

Participants with history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
Participants with history or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
Participants with clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
Participants with clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
Participants with use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Merksem

Other trials in Belgium

About this study

Official title: Open-Label, Randomized, 3-Way Crossover Design to Assess the Relative Bioavailability of JNJ-42756493 Tablets

The purpose of this study is to assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet.

Read the detailed description

This is an open-label (all people know the identity of the intervention), multi-period, randomized (study drug assigned by chance), single-dose, 3-way crossover study. The study consists of 21-day screening period, 3 open-label treatment periods with a minimum 21 (+-2)-day washout between doses, and end-of-study assessments 10 (+-2) days after the last dose. The duration of study is approximately 3 months. Participants will be randomized to 1 of 6 treatment sequences as follows: Treatment sequence 1=ABC, 2=BCA, 3=CAB, 4=ACB, 5=BAC AND 6=CBA. Treatment A=JNJ-42756493 current clinical formulation, 10 milligrams (mg) (2 tablets of 5 mg each). Treatment B= JNJ-42756493 Prototype Formulation I (G-025), 10 mg (2 tablets of 5 mg each) and Treatment C=JNJ-42756493 Prototype Formulation II (G-025), 10 mg (2 tablets of 5 mg each). Blood samples will be collected to determine pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: JNJ-42756493 Current Clinical Formulation (G-018), JNJ-42756493 Prototype Formulation I (G-025), JNJ-42756493 Prototype Formulation II (G-025)
Keywords: Healthy, JNJ-42756493

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-42756493 Current Clinical Formulation (G-018)Drug
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 Prototype Formulation I (G-025)Drug
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 Prototype Formulation II (G-025)Drug
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.

Study groups in NCT02466815
Study group	Role	What they receive
Treatment A, then Treatment B and then Treatment C	Experimental	Participants will receive treatment A (JNJ-42756493 10 milligram [mg] tablet, current clinical formulation [G-018] which uses milled active pharmaceutical ingredient [API]) in period 1, treatment B (JNJ-42756493 10 mg tablet, Prototype Formulation I [G-025] which uses coarser API) in period 2 and then treatment C (JNJ-42756493 10 mg tablet, Prototype Formulation II [G-025] which uses coarser API) in period 3. Receives: Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025); Drug: JNJ-42756493 Prototype Formulation II (G-025)
Treatment B, then Treatment C and then Treatment A	Experimental	Participants will receive treatment B in period 1, treatment C in period 2 and then treatment A in period 3. Receives: Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025); Drug: JNJ-42756493 Prototype Formulation II (G-025)
Treatment C, then Treatment A and then Treatment B	Experimental	Participants will receive treatment C in period 1, treatment A in period 2 and then treatment B in period 3. Receives: Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025); Drug: JNJ-42756493 Prototype Formulation II (G-025)
Treatment A, then Treatment C and then Treatment B	Experimental	Participants will receive treatment A in period 1, treatment C in period 2 and then treatment B in period 3. Receives: Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025); Drug: JNJ-42756493 Prototype Formulation II (G-025)
Treatment B, then Treatment A and then Treatment C	Experimental	Participants will receive treatment B in period 1, treatment A in period 2 and then treatment C in period 3. Receives: Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025); Drug: JNJ-42756493 Prototype Formulation II (G-025)
Treatment C, then Treatment B and then Treatment A	Experimental	Participants will receive treatment C in period 1, treatment B in period 2 and then treatment A in period 3. Receives: Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025); Drug: JNJ-42756493 Prototype Formulation II (G-025)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of JNJ-42756493
The Cmax is the maximum observed plasma JNJ-42756493 concentration. Relative bioavailability will be calculated by Cmax based on total drug concentrations.
Measured: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24]) of JNJ-42756493
AUC(0-24) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to 24 hours. Relative bioavailability will be calculated by AUC(0-24) based on total drug concentrations.
Measured: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (Clast) (AUC[0-last]) of JNJ-42756493
AUC(0-last) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to time of the last observed quantifiable concentration (Clast). Relative bioavailability will be calculated by AUC(0-last) based on total drug concentrations.
Measured: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time AUC (infinity) of JNJ-42756493
AUC (infinity) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(0-last) and Clast/lambda(z), in which lambda(z) is the first-order rate constant associated with the terminal portion of the curve. Relative bioavailability will be calculated by AUC (infinity) based on total drug concentrations.
Measured: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7

Secondary outcomes (1)

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to end of study (up to 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Aug 2015

First posted9 Jun 2015 (estimated)
Study startJun 2015
Primary completionAug 2015
Study completionAug 2015

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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02466815
Sponsor's protocol ID: CR107460
Other IDs: 42756493EDI1004, 2015-001583-19, 2015
Status last verified: Jan 2025
First submitted: 5 Jun 2015
Last updated: 3 Feb 2025
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Randomized, 3-Way Crossover Design to Assess the Relative Bioavailability of JNJ-42756493 Tablets
ClinicalTrials.gov ID: NCT02466815
Acronym / sponsor ID: CR107460
Conditions: Healthy
Keywords: Healthy, JNJ-42756493
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 9 Jun 2015 (estimated)
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 assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment A, then Treatment B and then Treatment C	Experimental	Drug: JNJ-42756493 Current Clinical Formulation (G-018), Drug: JNJ-42756493 Prototype Formulation I (G-025), Drug: JNJ-42756493 Prototype Formulation II (G-025)Participants will receive treatment A (JNJ-42756493 10 milligram [mg] tablet, current clinical formulation [G-018] which uses milled active pharmaceutical ingredient [API]) in period 1, treatment B (JNJ-42756493 10 mg tablet, Prototype Formulation I [G-025] which uses coarser API) in period 2 and then treatment C (JNJ-42756493 10 mg tablet, Prototype Formulation II [G-025] which uses coarser API) in period 3.
Treatment B, then Treatment C and then Treatment A	Experimental	Drug: JNJ-42756493 Current Clinical Formulation (G-018), Drug: JNJ-42756493 Prototype Formulation I (G-025), Drug: JNJ-42756493 Prototype Formulation II (G-025)Participants will receive treatment B in period 1, treatment C in period 2 and then treatment A in period 3.
Treatment C, then Treatment A and then Treatment B	Experimental	Drug: JNJ-42756493 Current Clinical Formulation (G-018), Drug: JNJ-42756493 Prototype Formulation I (G-025), Drug: JNJ-42756493 Prototype Formulation II (G-025)Participants will receive treatment C in period 1, treatment A in period 2 and then treatment B in period 3.
Treatment A, then Treatment C and then Treatment B	Experimental	Drug: JNJ-42756493 Current Clinical Formulation (G-018), Drug: JNJ-42756493 Prototype Formulation I (G-025), Drug: JNJ-42756493 Prototype Formulation II (G-025)Participants will receive treatment A in period 1, treatment C in period 2 and then treatment B in period 3.
Treatment B, then Treatment A and then Treatment C	Experimental	Drug: JNJ-42756493 Current Clinical Formulation (G-018), Drug: JNJ-42756493 Prototype Formulation I (G-025), Drug: JNJ-42756493 Prototype Formulation II (G-025)Participants will receive treatment B in period 1, treatment A in period 2 and then treatment C in period 3.
Treatment C, then Treatment B and then Treatment A	Experimental	Drug: JNJ-42756493 Current Clinical Formulation (G-018), Drug: JNJ-42756493 Prototype Formulation I (G-025), Drug: JNJ-42756493 Prototype Formulation II (G-025)Participants will receive treatment C in period 1, treatment B in period 2 and then treatment A in period 3.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants should be willing to adhere to the prohibitions and restrictions specified in this protocol
Woman must be either: postmenopausal (greater than (>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (follicle stimulating hormone [FSH]) >40 international unit per litre [IU/L]); surgically sterile
Woman must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug.
Man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Key exclusion criteria (5 listed)

Participants with history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
Participants with history or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
Participants with clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
Participants with clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
Participants with use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the 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
JNJ-42756493 Current Clinical Formulation (G-018)JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.	Drug	Treatment A, then Treatment B and then Treatment C, Treatment A, then Treatment C and then Treatment B, Treatment B, then Treatment A and then Treatment C, Treatment B, then Treatment C and then Treatment A, Treatment C, then Treatment A and then Treatment B, Treatment C, then Treatment B and then Treatment A
JNJ-42756493 Prototype Formulation I (G-025)JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.	Drug	Treatment A, then Treatment B and then Treatment C, Treatment A, then Treatment C and then Treatment B, Treatment B, then Treatment A and then Treatment C, Treatment B, then Treatment C and then Treatment A, Treatment C, then Treatment A and then Treatment B, Treatment C, then Treatment B and then Treatment A
JNJ-42756493 Prototype Formulation II (G-025)JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.	Drug	Treatment A, then Treatment B and then Treatment C, Treatment A, then Treatment C and then Treatment B, Treatment B, then Treatment A and then Treatment C, Treatment B, then Treatment C and then Treatment A, Treatment C, then Treatment A and then Treatment B, Treatment C, then Treatment B and then Treatment A

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of JNJ-42756493
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
The Cmax is the maximum observed plasma JNJ-42756493 concentration. Relative bioavailability will be calculated by Cmax based on total drug concentrations.
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24]) of JNJ-42756493
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
AUC(0-24) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to 24 hours. Relative bioavailability will be calculated by AUC(0-24) based on total drug concentrations.
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (Clast) (AUC[0-last]) of JNJ-42756493
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
AUC(0-last) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to time of the last observed quantifiable concentration (Clast). Relative bioavailability will be calculated by AUC(0-last) based on total drug concentrations.
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time AUC (infinity) of JNJ-42756493
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
AUC (infinity) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(0-last) and Clast/lambda(z), in which lambda(z) is the first-order rate constant associated with the terminal portion of the curve. Relative bioavailability will be calculated by AUC (infinity) based on total drug concentrations.

1 secondary outcome

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Screening up to end of study (up to 3 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 3 Feb 2025.

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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?

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 5 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: finished, as of the sponsor's last update on 3 Feb 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 Belgium. 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?

Maximum Observed Plasma Concentration (Cmax) of JNJ-42756493 (time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02466815.

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 3 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.