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A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants

NCT01986491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-11-18

No results posted yet for this study

Summary

The purpose of the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.

Conditions

  • Healthy

Interventions

DRUG

JNJ 39393406 30 mg solid X

Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).

DRUG

JNJ 39393406 30 mg solid Y

Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

DRUG

JNJ 39393406 120 mg solid X

Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).

DRUG

JNJ 39393406 120 mg solid Y

Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

DRUG

JNJ 39393406 30 mg solution

Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Belgium

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 NCT01986491 on ClinicalTrials.gov