MedTrace Logo

TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions

NCT01291563 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-11-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the QT/QTc interval in healthy volunteers.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Moxifloxacin

1 capsule of moxifloxacin (400 mg/capsule) on Day 2

DRUG

TMC207

8 tablets of TMC207 (100 mg/tablet) on Day 1

DRUG

TMC207 placebo

8 tablets of TMC207 placebo on Day 1

DRUG

Moxifloxacin placebo

1 capsule of moxifloxacin placebo on Day 2

Sponsors & Collaborators

  • Tibotec BVBA

    lead INDUSTRY

Principal Investigators

  • Tibotec-Virco Virology BVBA Clinical Trial · Tibotec BVBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Completion
2011-04-30

More Related Trials

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 NCT01291563 on ClinicalTrials.gov