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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
12
25 mg JNJ-42165279 tablet will be administered orally.
Matching placebo tablet will be administered orally.
WCCT Global, LLC
Cypress, California, United States
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.
Time frame: 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.
Time frame: Day -1 up to approximately 28 days
Part 1: Plasma Concentration of JNJ-42165279
Plasma concentration of JNJ-42165279 will be reported.
Time frame: Up to Day 4
Part 2: Plasma Concentration of JNJ-42165279
Plasma concentration of JNJ-42165279 will be reported.
Time frame: Up to Day 14
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).
Time frame: 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).
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 and Days 10 to 14