A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants
- Registration Number
- NCT03564379
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Single Dose Part Placebo Participants will receive a single oral dose of 25 mg JNJ-42165279 or placebo tablet under fasted condition in the morning on Day 1. Part 1: Single Dose Part JNJ-42165279 Participants 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 Placebo 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. Part 2: Multiple Dose Part JNJ-42165279 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.
- Primary Outcome Measures
Name Time Method Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability 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: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability 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 1: Plasma Concentration of JNJ-42165279 Up to Day 4 Plasma concentration of JNJ-42165279 will be reported.
Part 2: Plasma Concentration of JNJ-42165279 Up to Day 14 Plasma concentration of JNJ-42165279 will be reported.
- Secondary Outcome Measures
Name Time Method Part 1: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin) Up to Day 4 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).
Part 2: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin) Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days) 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).
Part 1: Minimum Observed Fatty Acid Amide Hydrolase (FAAH) Activity in White Blood Cells (WBC) Concentration (Rmin) Up to Day 4 Rmin is the minimum observed FAAH activity in WBC concentration during a dosing interval (may or may not be the trough concentration).
Part 2: Minimum Observed FAAH Activity in WBC Concentration (Rmin) Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days) Rmin is the minimum observed FAAH activity in WBC concentration during a dosing interval (may or may not be the trough concentration).
Part 1: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma Fatty Acid Amides (FAA) Baseline Up to Day 4 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.
Part 2: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma FAA Baseline, Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days) 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.
Part 2: Plasma Concentrations of FAAs (AEA, PEA and OEA) Day 1 and Days 10 to 14 Plasma concentration of FAAs including AEA, PEA, and OEA will be reported.
Part 1: Plasma Concentrations of Fatty Acid Amides (FAAs - N-Arachidonoyl ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA]) Up to Day 3 Plasma concentration of FAAs including AEA, PEA, and OEA will be reported.
Trial Locations
- Locations (1)
WCCT Global, LLC
🇺🇸Cypress, California, United States