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TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

NCT01269294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-05-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of TMC435 on the results of electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis C virus infection.

Conditions

  • Hepatitis C

Interventions

DRUG

TMC435

2 capsules of 75 mg once daily for 7 days in Treatment A

DRUG

Placebo for TMC435

4 placebo capsules once daily for 7 days in Treatment C

DRUG

TMC435

2 capsules of 75 mg and 2 capsules of 100 mg once daily for 7 days in Treatment B

DRUG

Placebo for TMC435

2 placebo capsules once daily for 7 days in Treatment A

DRUG

Moxifloxacin

1 tablet of 400 mg on Day 7 of Treatment C

DRUG

Placebo for moxifloxacin

1 placebo tablet on Day 7 of Treatments A, B and D

DRUG

Placebo for TMC435

4 placebo capsules once daily for 7 days in Treatment D

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

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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 NCT01269294 on ClinicalTrials.gov