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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564379
• Other study ID #: CR108467
• Secondary ID: 42165279EDI1007
• Status: Completed
• Phase: Phase 1
• Start date: June 12, 2018
• Est. completion date: August 13, 2018

Study information

• Verified date: October 2018
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-42165279
25 mg JNJ-42165279 tablet will be administered orally.
• Placebo
Matching placebo tablet will be administered orally.

Locations

Country	Name	City	State
United States	WCCT Global, LLC	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Part 1: Plasma Concentration of JNJ-42165279	Plasma concentration of JNJ-42165279 will be reported.	Up to Day 4
Primary	Part 2: Plasma Concentration of JNJ-42165279	Plasma concentration of JNJ-42165279 will be reported.	Up to Day 14
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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