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.

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Efavirenz; Moxifloxacin; Rilpivirine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.