A Phase 1 interventional study of JNJ-42165279 50 mg and JNJ-42165279 100 mg in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral dose administration.
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) trial that will be conducted in two parts. Thirty two (32) healthy participants are planned to be included in total, in four cohorts (groups). Participants in each cohort will receive JNJ-42165279 (n=6) or placebo (n=2) once-daily for 10 consecutive days. In Part 1, two cohorts of healthy male participants, 18 to 55 years of age, will be enrolled. Cohort A will receive 50 mg JNJ-42165279 or placebo for 10 days, and Cohort B will receive 30 mg JNJ-42165279 or placebo for 10 days. In Part 2, Cohort C will consist of 8 healthy female participants of non-childbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. Cohort D will consist of 8 healthy elderly male or female participants, from 65 to 85 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. The dose may be adapted before each cohort starts based on available data. The maximum dose will not exceed 100 mg once-daily. For all participants, this study will consist of an eligibility screening examination (between 28 and 3 days prior to the first dose administration), a double-blind treatment phase consisting of 2 days before dosing, 10 dosing days (Day 1 to 10), 4 days after dosing (Day 11 to 14), and a follow-up examination (within 7 to 14 days after last dose administration). The total study duration for each participant will not exceed 8 weeks.
Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.
Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.
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Exclusion Criteria:
Healthy male participants, 18 to 55 years of age.
Drug: JNJ-42165279 50 mg · Drug: Placebo
Healthy male participants, 18 to 55 years of age.
Drug: JNJ-42165279 30 mg · Drug: Placebo
Healthy female participants of nonchildbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age.
Drug: JNJ-42165279 100 mg · Drug: Placebo
Healthy elderly male or female participants, from 65 to 85 years of age.
Drug: JNJ-42165279 100 mg · Drug: Placebo
JNJ-42165279 50 mg orally administered once daily for 10 days.
JNJ-42165279 100 mg orally administered once daily for 10 days.
JNJ-42165279 30 mg orally administered once daily for 10 days.
Matching placebo orally administered once daily for 10 days.
Plasma concentrations of JNJ-42165279
Time frame: 2 weeks
Urine concentrations of JNJ-42165279
Time frame: 2 weeks
Concentrations in cerebrospinal fluid of JNJ-42165279
Time frame: 2 weeks
The number of participants with adserve events as a measure of safety and tolerability
Time frame: Approximately 8 weeks
Enzyme fatty acid amide hydrolase inhibition, as measured in white blood cells (WBCs)
Time frame: Approximately 4 weeks
Plasma concentrations of N-arachidonoylethanolamine (anandamide)
Time frame: 2 weeks
Plasma concentrations of palmitoylethanolamide
Time frame: 2 weeks
Plasma concentrations of oleoylethanolamide
Time frame: 2 weeks
Serum concentrations of prolactin
Time frame: 10 days
Saliva concentrations of cortisol
Time frame: 10 days
Concentrations in cerebrospinal fluid of N-arachidonoylethanolamine (anandamide) or its metabolites
Time frame: 9 days
Concentrations in cerebrospinal fluid of palmitoylethanolamide or its metabolites
Time frame: 9 days
Concentrations in cerebrospinal fluid of oleoylethanolamide or its metabolites
Time frame: 9 days
The record gives a start of Oct 2013, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: JNJ-42165279
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