TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers.

NCT00744809 | Completed Phase 1

• 1 other identifier: CR015088
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart conduction and heart rhythm) in healthy volunteers. In a separate panel of healthy volunteers, the effect of efavirenz (EFV) 600 mg daily on the QT/QTc interval will be evaluated.

Conditions

Human Volunteers

Keywords

TMC278-C152; TMC278-TiDP6-C152; Healthy Volunteers; QT/QTc interval

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of TMC278 25 mg daily at steady state on the QT/QTc interval in healthy volunteers.

Secondary Outcomes (1)

• To evaluate steady-state PK of TMC278 25 mg daily in healthy volunteers; to evaluate the effect of EFV 600 mg daily and separately, a single dose of moxifloxican (400 mg) at steady state, on the QT/QTc interval in healthy volunteers

Interventions

TMC278; Moxifloxacin; Efavirenz DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must: be non-smokers (no tobacco products, nicotine or nicotine containing products of any kind for at least 1 year)
• have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
• be healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram, vital signs and the results of routine blood and urine tests at screening
• have a normal 12-lead ECG at screening and on Day -1 (safety ECG) of the first treatment period.

You may not qualify if:

• Patients must not: have a positive HIV-1 or -2 test at trial screening
• be a female of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods from screening onwards until at least 30 days after last intake of trial medication
• have a history or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
• have Hepatitis A, B or C infection at trial screening
• have participated in an investigational drug trial within 60 days prior to the first intake of trial medication
• have a history of clinically relevant heart rhythm disturbances
• have blood pressure (BP) outside of normal range (sitting systolic blood pressure \<90 or \>140 mmHg and/or diastolic blood pressure \<40 or \>90 mmHg) at screening or on Day -1 of the first treatment period.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Links

• Clinical Study Report Synopsis of TMC278-TiDP6-C152: A study to assess the effects of TMC278 and Efavirenz (EFV) on the QT/QTc interval (heart repolarization) in healthy volunteers.

MeSH Terms

Interventions

Rilpivirine; Moxifloxacin; efavirenz

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2010-03