HealthyPhase 1NCT03564379
A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants
A Phase 1 study testing JNJ-42165279 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 assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42165279
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 13 Aug 2018
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- A man who is sexually active with a woman of childbearing potential, and has not had a vasectomy with confirmation of azoospermia, must agree to use a barrier method of birth control during the study and for 3 months after receiving the last dose of study drug, and his female partner must also use a highly effective form of birth control at least one month prior to the first study dose and continuing until 3 months after the final study dose. Acceptable barrier methods are male condoms with spermicide, and for the female partner a diaphragm or cervical cap with appropriate spermicidal foam, cream, or gel. Highly effective forms of birth control for the female partner are prescribed hormonal implants, contraceptive patches, contraceptive injections, oral contraceptives, and intrauterine device (IUD)
- Body Mass Index (BMI; weight/height^2 [kilogram per meter square {kg/m^2}]) between 18.0 and 30.0 kg/m^2 (inclusive), and body weight not less than 50.0 kilogram (kg)
- Blood pressure (BP) (after the participant is standing for 3 minutes, supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic (orthostatic cut-off, a fall in systolic BP of at least 20 mmHg or diastolic BP of at least 10 mmHg when a person assumes a standing position is exclusionary). If BP is out of range, up to 2 repeated assessments are permitted
Who cannot join
- Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening (and at admission to the study center) as deemed appropriate by the investigator
- Known allergy, hypersensitivity, or intolerance to JNJ-42165279 or its excipients
- Any Grade 2 laboratory toxicity
- History of clinically significant drug and/or food allergies
- History of epilepsy or fits or unexplained black-outs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration.
- Conditions
- Healthy
- Being tested
- JNJ-42165279, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42165279Drug
25 mg JNJ-42165279 tablet will be administered orally.
PlaceboDrug
Matching placebo tablet will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Dose Part | Experimental | Participants will receive a single oral dose of 25 mg JNJ-42165279 or placebo tablet under fasted condition in the morning on Day 1. Receives: Drug: JNJ-42165279; Drug: Placebo |
| Part 2: Multiple Dose Part | Experimental | After a washout period of at least 10 days, same participants from Part 1 will receive multiple daily dosing of 25 mg JNJ-42165279 or placebo tablet for 10 days. Receives: Drug: JNJ-42165279; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Screening up to Day 4
Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Day -1 up to approximately 28 days
Part 1: Plasma Concentration of JNJ-42165279
Plasma concentration of JNJ-42165279 will be reported.
Measured: Up to Day 4
Part 2: Plasma Concentration of JNJ-42165279
Plasma concentration of JNJ-42165279 will be reported.
Measured: Up to Day 14
Secondary outcomes (8)
Part 1: Minimum Observed Fatty Acid Amide Hydrolase (FAAH) Activity in White Blood Cells (WBC) Concentration (Rmin)
Rmin is the minimum observed FAAH activity in WBC concentration during a dosing interval (may or may not be the trough concentration).
Measured: Up to Day 4
Part 2: Minimum Observed FAAH Activity in WBC Concentration (Rmin)
Rmin is the minimum observed FAAH activity in WBC concentration during a dosing interval (may or may not be the trough concentration).
Measured: Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
Part 1: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin)
tmin is the time to the minimum observed FAAH activity in WBC concentration occurred during a dosing interval (may or may not be the trough concentration).
Measured: Up to Day 4
Part 2: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin)
tmin is the time to the minimum observed FAAH activity in WBC concentration occurred during a dosing interval (may or may not be the trough concentration).
Measured: Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
Part 1: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma Fatty Acid Amides (FAA)
Maximum percent change in FAAH activity in WBCs, compared to baseline (that is, predose) value of Plasma FAA (ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA]) will be observed.
Measured: Baseline Up to Day 4
Part 2: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma FAA
Maximum percent change in FAAH activity in WBCs, compared to baseline (that is, predose) value of Plasma FAA (AEA, PEA, and OEA) will be observed.
Measured: Baseline, Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
Part 1: Plasma Concentrations of Fatty Acid Amides (FAAs - N-Arachidonoyl ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA])
Plasma concentration of FAAs including AEA, PEA, and OEA will be reported.
Measured: Up to Day 3
Part 2: Plasma Concentrations of FAAs (AEA, PEA and OEA)
Plasma concentration of FAAs including AEA, PEA, and OEA will be reported.
Measured: Day 1 and Days 10 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start12 Jun 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- NCT03564379
- Sponsor's protocol ID
- CR108467
- Other IDs
- 42165279EDI1007
- Status last verified
- Apr 2025
- First submitted
- 11 Jun 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT03564379
- Acronym / sponsor ID
- CR108467
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 20 Jun 2018 (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 assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Dose Part | Experimental | Drug: JNJ-42165279, Drug: PlaceboParticipants will receive a single oral dose of 25 mg JNJ-42165279 or placebo tablet under fasted condition in the morning on Day 1. |
| Part 2: Multiple Dose Part | Experimental | Drug: JNJ-42165279, Drug: PlaceboAfter a washout period of at least 10 days, same participants from Part 1 will receive multiple daily dosing of 25 mg JNJ-42165279 or placebo tablet for 10 days. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- A man who is sexually active with a woman of childbearing potential, and has not had a vasectomy with confirmation of azoospermia, must agree to use a barrier method of birth control during the study and for 3 months after receiving the last dose of study drug, and his female partner must also use a highly effective form of birth control at least one month prior to the first study dose and continuing until 3 months after the final study dose. Acceptable barrier methods are male condoms with spermicide, and for the female partner a diaphragm or cervical cap with appropriate spermicidal foam, cream, or gel. Highly effective forms of birth control for the female partner are prescribed hormonal implants, contraceptive patches, contraceptive injections, oral contraceptives, and intrauterine device (IUD)
- Body Mass Index (BMI; weight/height^2 [kilogram per meter square {kg/m^2}]) between 18.0 and 30.0 kg/m^2 (inclusive), and body weight not less than 50.0 kilogram (kg)
- Blood pressure (BP) (after the participant is standing for 3 minutes, supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic (orthostatic cut-off, a fall in systolic BP of at least 20 mmHg or diastolic BP of at least 10 mmHg when a person assumes a standing position is exclusionary). If BP is out of range, up to 2 repeated assessments are permitted
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening (and at admission to the study center) as deemed appropriate by the investigator
- Known allergy, hypersensitivity, or intolerance to JNJ-42165279 or its excipients
- Any Grade 2 laboratory toxicity
- History of clinically significant drug and/or food allergies
- History of epilepsy or fits or unexplained black-outs
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-4216527925 mg JNJ-42165279 tablet will be administered orally. | Drug | Part 1: Single Dose Part, Part 2: Multiple Dose Part |
| PlaceboMatching placebo tablet will be administered orally. | Drug | Part 1: Single Dose Part, Part 2: Multiple Dose Part |
Primary outcome
Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Screening up to Day 4
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Day -1 up to approximately 28 days
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Part 1: Plasma Concentration of JNJ-42165279
Time frame: Up to Day 4
Plasma concentration of JNJ-42165279 will be reported.
Part 2: Plasma Concentration of JNJ-42165279
Time frame: Up to Day 14
Plasma concentration of JNJ-42165279 will be reported.
8 secondary outcomes
Part 1: Minimum Observed Fatty Acid Amide Hydrolase (FAAH) Activity in White Blood Cells (WBC) Concentration (Rmin)
Time frame: Up to Day 4
Part 2: Minimum Observed FAAH Activity in WBC Concentration (Rmin)
Time frame: Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
Part 1: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin)
Time frame: Up to Day 4
Part 2: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin)
Time frame: Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
Part 1: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma Fatty Acid Amides (FAA)
Time frame: Baseline Up to Day 4
Part 2: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma FAA
Time frame: Baseline, Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
Part 1: Plasma Concentrations of Fatty Acid Amides (FAAs - N-Arachidonoyl ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA])
Time frame: Up to Day 3
Part 2: Plasma Concentrations of FAAs (AEA, PEA and OEA)
Time frame: Day 1 and Days 10 to 14
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 27 Apr 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?
A Phase 1 study testing JNJ-42165279 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 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 27 Apr 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?
Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Screening up to Day 4). 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?
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 27 Apr 2025.