Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Participants

Healthy Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42165279 in Healthy Young and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964651
• Other study ID #: CR102575
• Secondary ID: 42165279EDI10022
• Status: Completed
• Phase: Phase 1
• First received: October 14, 2013
• Last updated: December 2, 2014
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive

• Nonsmoker

• Healthy men between 18 and 55 years, inclusive (Cohorts A and B)

• Healthy women between 18 and 58 years, inclusive (Cohort C)

• Healthy men and women between 65 and 85 years of age, inclusive (Cohort D)

• Men who are sexually active with a woman of childbearing potential and have not had a vasectomy 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. In addition, their female partners should also use an appropriate method of birth control for at least the same duration (Cohorts A, B, and D)

• Not be of childbearing potential due to either tubal ligation or hysterectomy, or who are postmenopausal (Cohorts C and D)

Exclusion Criteria:

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission

• Clinically significant abnormal physical examination, vital signs or electrocardiogram at screening or admission

• History of, or current, significant medical illness including (but not limited to) cardiac disease, hematological disease, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant

• History of epilepsy or fits or unexplained black-outs

• Cohorts A and B only: a contraindication for spinal puncture

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-42165279 50 mg
JNJ-42165279 50 mg orally administered once daily for 10 days.
• JNJ-42165279 100 mg
JNJ-42165279 100 mg orally administered once daily for 10 days.
• JNJ-42165279 30 mg
JNJ-42165279 30 mg orally administered once daily for 10 days.
• Placebo
Matching placebo orally administered once daily for 10 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of JNJ-42165279		2 weeks	No
Primary	Urine concentrations of JNJ-42165279		2 weeks	No
Primary	Concentrations in cerebrospinal fluid of JNJ-42165279		2 weeks	No
Primary	The number of participants with adserve events as a measure of safety and tolerability		Approximately 8 weeks	No
Secondary	Enzyme fatty acid amide hydrolase inhibition, as measured in white blood cells (WBCs)		Approximately 4 weeks	No
Secondary	Plasma concentrations of N-arachidonoylethanolamine (anandamide)		2 weeks	No
Secondary	Plasma concentrations of palmitoylethanolamide		2 weeks	No
Secondary	Plasma concentrations of oleoylethanolamide		2 weeks	No
Secondary	Serum concentrations of prolactin		10 days	No
Secondary	Saliva concentrations of cortisol		10 days	No
Secondary	Concentrations in cerebrospinal fluid of N-arachidonoylethanolamine (anandamide) or its metabolites		9 days	No
Secondary	Concentrations in cerebrospinal fluid of palmitoylethanolamide or its metabolites		9 days	No
Secondary	Concentrations in cerebrospinal fluid of oleoylethanolamide or its metabolites		9 days	No