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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants

NCT01964872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-09-12

No results posted yet for this study

Summary

The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

JNJ-38877618: Part 1a

Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

DRUG

JNJ-38877618: Part 1b

Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

DRUG

JNJ-38877618: Part 1c (optional)

Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

DRUG

JNJ-38877618: Part 2

Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

DRUG

JNJ-38877618: Part 3

Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.

DRUG

JNJ-38877618: Part 4 (optional)

Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.

DRUG

Placebo: Parts 1a, 2, 3, and 4 (optional)

Administered orally matched to study drug

Sponsors & Collaborators

  • Janssen Cilag N.V./S.A.

    lead INDUSTRY

Principal Investigators

  • Janssen Cilag N.V./S.A., Belgium Clinical Trial · Janssen Cilag N.V./S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964872 on ClinicalTrials.gov