A Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of JNJ-42165279 in Healthy Japanese Male Participants

NCT03564379 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10846742165279EDI1007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Day -1 up to approximately 28 days

• Part 1: Plasma Concentration of JNJ-42165279

  Plasma concentration of JNJ-42165279 will be reported.

  Up to Day 4

• Part 2: Plasma Concentration of JNJ-42165279

  Plasma concentration of JNJ-42165279 will be reported.

  Up to Day 14

Secondary Outcomes (8)

• Part 1: Minimum Observed Fatty Acid Amide Hydrolase (FAAH) Activity in White Blood Cells (WBC) Concentration (Rmin)

  Up to Day 4

• Part 2: Minimum Observed FAAH Activity in WBC Concentration (Rmin)

  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)

  Up to Day 4

• 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)

• 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

Study Arms (2)

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.

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.

Drug: JNJ-42165279; Drug: Placebo

Interventions

JNJ-42165279 DRUG

25 mg JNJ-42165279 tablet will be administered orally.

Part 1: Single Dose Part; Part 2: Multiple Dose Part

Placebo DRUG

Matching placebo tablet will be administered orally.

Part 1: Single Dose Part; Part 2: Multiple Dose Part

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

WCCT Global, LLC

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

JNJ-42165279

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 20, 2018
• Study Start: June 12, 2018
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)