VX-950-TiDP24-C136 - A Trial to Evaluate the Effect of Telaprevir (TVR) on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Tibotec BVBA
• Collaborator: Vertex Pharmaceuticals Incorporated
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Non-smoking for at least 6 months prior to screening

• A body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to30 kg/m2, extremes included

• Otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of laboratory tests and a urinalysis carried out at screening

Exclusion Criteria:

• Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week from 14 days before the first intake of study medication and of an average of more than five 240-mL servings of coffee or other caffeinated beverage (e.g. tea, cola) per day from screening onwards

• A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs during the screening period

• Participation in a clinical study involving administration of an investigational drug within 2 months or 5 half lives (whichever is longer) prior to the screening visit

• Donation of any blood or having had a significant loss of blood within 3 months, or donation of more than 1 unit of plasma within 7 days before the first dose of study drug

• Male patients with female partners who are planning to become pregnant during the study or within 90 days of the last dose of study medication and female patients of childbearing potential who are pregnant or planning to become pregnant within 90 days of the completion of the study, who are not using adequate contraception, or who are breastfeeding