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A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

NCT01571570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-06-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. In addition, this study is to assess for the acceptability of the taste of both liquid formulations.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TMC435 150 mg capsule

single oral dose of 150 mg TMC435 150 mg capsule

DRUG

TMC435 150 mg oral suspension (20 mg/mL)

single oral dose of 150 mg TMC435 oral suspension

DRUG

TMC435 150 mg oral solution (10 mg/mL)

single oral dose of 150 mg TMC435 oral solution

DRUG

TMC435 150 mg capsule concept K

single oral dose of 150 mg TMC435 capsule concept K

DRUG

TMC435 150 mg capsule concept L

single oral dose of 150 mg TMC435 capsule concept L

Sponsors & Collaborators

  • Janssen R&D Ireland

    lead INDUSTRY

Principal Investigators

  • Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01571570 on ClinicalTrials.gov