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A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers

NCT01454245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2013-01-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335 will also be evaluated during the study.

Conditions

  • Healthy

Interventions

DRUG

JNJ-39439335

Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods.

DRUG

JNJ-39439335

Part 1:Type=1, unit=mg, number=25, form=capsule, route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods. or Part 1:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

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 NCT01454245 on ClinicalTrials.gov