Clinical trial NCT03564379: A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Screening up to Day 4
measure: Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Day -1 up to approximately 28 days
measure: Part 1: Plasma Concentration of JNJ-42165279
timeFrame: Up to Day 4
measure: Part 2: Plasma Concentration of JNJ-42165279
timeFrame: Up to Day 14
Secondary outcomes:
measure: Part 1: Minimum Observed Fatty Acid Amide Hydrolase (FAAH) Activity in White Blood Cells (WBC) Concentration (Rmin)
timeFrame: Up to Day 4
measure: Part 2: Minimum Observed FAAH Activity in WBC Concentration (Rmin)
timeFrame: Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
measure: Part 1: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin)
timeFrame: Up to Day 4
measure: Part 2: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin)
timeFrame: Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
measure: Part 1: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma Fatty Acid Amides (FAA)
timeFrame: Baseline Up to Day 4
measure: Part 2: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma FAA
timeFrame: Baseline, Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
measure: Part 1: Plasma Concentrations of Fatty Acid Amides (FAAs - N-Arachidonoyl ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA])
timeFrame: Up to Day 3
measure: Part 2: Plasma Concentrations of FAAs (AEA, PEA and OEA)
timeFrame: Day 1 and Days 10 to 14
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, LLC
state: California
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: