A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.

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

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Ritonavir; Simeprevir

Criteria

Inclusion Criteria:

• non-smoking for at least 3 months prior to selection

• normal weight as defined by a Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included

• Informed Consent Form signed voluntarily, prior to the first trial related activity

• normal 12-lead electrocardiogram (ECG) at screening

• healthy on the basis of a medical evaluation and results fo the laboratory tests at screening.

Exclusion Criteria:

• past history of heart arrhythmias,

• female, except if postmenopausal for more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)

• history or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use

• hepatitis A, B and C infections or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infections at study screening

• donation of blood or plasma in the 60 days preceding the first intake of trial medication