HealthyPhase 1NCT01732237
A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants
A Phase 1 study testing JNJ-42396302, JNJ-42692507 and JNJ-53773187 in people with Healthy, run by Janssen-Cilag International NV.
Trial summary
The purpose of the study is to investigate the pharmacokinetics (what the body does to the medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single oral dose of 100 micrograms under fasted conditions in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42396302, JNJ-42692507 and JNJ-53773187
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Oct 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant should be healthy male on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis
- Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
- Have a blood pressure between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
- Agrees to protocol-defined use of effective contraception
Who cannot join
- A positive human immunodeficiency virus-type 1 or type 2 test and Hepatitis A, B or C infection at screening or admission
- Participant with abnormal physical, vital or laboratory values
- Currently active cardiovascular, bronchospastic respiratory disease, dyspnea, diabetes mellitus, movement disorder and infectious disease
About this study
Official title: A Single Dose Study to Investigate the Pharmacokinetics of an Oral Microdose of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Subjects
The purpose of the study is to investigate the pharmacokinetics (what the body does to the medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single oral dose of 100 micrograms under fasted conditions in healthy male participants.
Read the detailed description
This is a phase I, open-label (all people know the identity of the intervention) and parallel-group (each group of patients will be treated at the same time), randomized (the study medication is assigned by chance) study in healthy male participants, to investigate the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first dose of study medication), a treatment phase, and a follow up phase. In the treatment phase, participants will be divided into 3 treatment groups with 6 participants each, to receive a single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be approximately 4 weeks.
- Conditions
- Healthy
- Being tested
- JNJ-42396302, JNJ-42692507, JNJ-53773187
- Keywords
- Healthy, JNJ-42396302, JNJ-42692507, JNJ-53773187, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42396302Drug
A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
JNJ-42692507Drug
A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
JNJ-53773187Drug
A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42396302 | Experimental | Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. Receives: Drug: JNJ-42396302 |
| JNJ-42692507 | Experimental | Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. Receives: Drug: JNJ-42692507 |
| JNJ-53773187 | Experimental | Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. Receives: Drug: JNJ-53773187 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-42396302
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-42396302
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-53773187
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-53773187
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-42692507
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-42692507
Measured: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Secondary outcomes (1)
Number of patients with adverse events
Measured: within 7 days after the last dose of the study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
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.
- 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732237
- Sponsor's protocol ID
- CR100878
- Other IDs
- 42396302EDI1003
- Status last verified
- Sep 2013
- First submitted
- 19 Nov 2012
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Investigate the Pharmacokinetics of an Oral Microdose of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01732237
- Acronym / sponsor ID
- CR100878
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-42396302, JNJ-42692507, JNJ-53773187, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Nov 2012 (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 the study is to investigate the pharmacokinetics (what the body does to the medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single oral dose of 100 micrograms under fasted conditions in healthy male participants.
Detailed description
This is a phase I, open-label (all people know the identity of the intervention) and parallel-group (each group of patients will be treated at the same time), randomized (the study medication is assigned by chance) study in healthy male participants, to investigate the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first dose of study medication), a treatment phase, and a follow up phase. In the treatment phase, participants will be divided into 3 treatment groups with 6 participants each, to receive a single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JNJ-42396302 | Experimental | Drug: JNJ-42396302Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. |
| JNJ-42692507 | Experimental | Drug: JNJ-42692507Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. |
| JNJ-53773187 | Experimental | Drug: JNJ-53773187Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant should be healthy male on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis
- Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
- Have a blood pressure between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
- Agrees to protocol-defined use of effective contraception
Key exclusion criteria (3 listed)
- A positive human immunodeficiency virus-type 1 or type 2 test and Hepatitis A, B or C infection at screening or admission
- Participant with abnormal physical, vital or laboratory values
- Currently active cardiovascular, bronchospastic respiratory disease, dyspnea, diabetes mellitus, movement disorder and infectious disease
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-42396302A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. | Drug | JNJ-42396302 |
| JNJ-42692507A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. | Drug | JNJ-42692507 |
| JNJ-53773187A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water. | Drug | JNJ-53773187 |
Primary outcome
Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-42396302
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-42396302
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-53773187
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-53773187
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Area under the plasma concentration time curve for JNJ-42692507
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
Apparent terminal elimination half-life of JNJ-42692507
Time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
1 secondary outcome
Number of patients with adverse events
Time frame: within 7 days after the last dose of the study medication
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 10 Sep 2013.
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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-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-42396302, JNJ-42692507 and JNJ-53773187 in people with Healthy, run by Janssen-Cilag International NV.
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 4 inclusion and 3 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 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 analyte concentration (Cmax) of JNJ-42396302 (time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours). The study lists 12 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 10 Sep 2013.