NCT01964651

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

October 14, 2013

Last Update Submit

December 2, 2014

Conditions

Healthy

Keywords

HealthyJNJ-42165279PharmacokineticsElderlyYoung

Outcome Measures

Primary Outcomes (4)

  • Plasma concentrations of JNJ-42165279

    2 weeks

  • Urine concentrations of JNJ-42165279

    2 weeks

  • Concentrations in cerebrospinal fluid of JNJ-42165279

    2 weeks

  • The number of participants with adserve events as a measure of safety and tolerability

    Approximately 8 weeks

Secondary Outcomes (9)

  • Enzyme fatty acid amide hydrolase inhibition, as measured in white blood cells (WBCs)

    Approximately 4 weeks

  • Plasma concentrations of N-arachidonoylethanolamine (anandamide)

    2 weeks

  • Plasma concentrations of palmitoylethanolamide

    2 weeks

  • Plasma concentrations of oleoylethanolamide

    2 weeks

  • Serum concentrations of prolactin

    10 days

  • +4 more secondary outcomes

Study Arms (4)

Cohort A (Part 1)

EXPERIMENTAL

Healthy male participants, 18 to 55 years of age.

Drug: JNJ-42165279 50 mgDrug: Placebo

Cohort B (Part 1)

EXPERIMENTAL

Healthy male participants, 18 to 55 years of age.

Drug: JNJ-42165279 30 mgDrug: Placebo

Cohort C (Part 2)

EXPERIMENTAL

Healthy female participants of nonchildbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age.

Drug: JNJ-42165279 100 mgDrug: Placebo

Cohort D (Part 2)

EXPERIMENTAL

Healthy elderly male or female participants, from 65 to 85 years of age.

Drug: JNJ-42165279 100 mgDrug: Placebo

Interventions

JNJ-42165279 50 mgDRUG

JNJ-42165279 50 mg orally administered once daily for 10 days.

Cohort A (Part 1)
JNJ-42165279 100 mgDRUG

JNJ-42165279 100 mg orally administered once daily for 10 days.

Cohort C (Part 2)Cohort D (Part 2)
JNJ-42165279 30 mgDRUG

JNJ-42165279 30 mg orally administered once daily for 10 days.

Cohort B (Part 1)
PlaceboDRUG

Matching placebo orally administered once daily for 10 days.

Cohort A (Part 1)Cohort B (Part 1)Cohort C (Part 2)Cohort D (Part 2)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

JNJ-42165279

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 17, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

BE(1)