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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-42165279; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Dose Part; 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; 25 mg JNJ-42165279 tablet will be administered orally.; Drug: Placebo; Matching placebo tablet will be administered orally.
Experimental: Part 2: Multiple Dose Part; 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; 25 mg JNJ-42165279 tablet will be administered orally.; Drug: Placebo; Matching placebo tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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.	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.	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.	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.	Day 1 and Days 10 to 14

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; JNJ-42165279
• Other Study ID Numbers: CR108467; 42165279EDI1007 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No