WCCT Global, LLC
Cypress, California, 90630, United States
NCT Number: NCT03564379
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.
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Notify Me20 year–55 year
Male
Interventional
Phase 1
Cypress, California, 90630, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
25 mg JNJ-42165279 tablet will be administered orally.
Matching placebo tablet will be administered orally.
Time frame: Screening up to Day 4
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
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: Up to Day 4
Plasma concentration of JNJ-42165279 will be reported.
Time frame: Up to Day 14
Plasma concentration of JNJ-42165279 will be reported.
Time frame: Up to Day 4
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)
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
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)
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: Baseline Up to Day 4
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, Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days)
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: Up to Day 3
Plasma concentration of FAAs including AEA, PEA, and OEA will be reported.
Time frame: Day 1 and Days 10 to 14
Plasma concentration of FAAs including AEA, PEA, and OEA will be reported.
Janssen Research & Development, LLC
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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