VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir

Launched by TIBOTEC BVBA · Dec 2, 2010

Keywords

ClinConnect Summary

This is an open-label, randomized (the order in which you receive the treatment sessions is determined by chance, like tossing a coin), crossover (participants will receive different interventions sequentially during the trial) study in healthy participants to investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of raltegravir 400 mg, twice a day, and vice versa. The study population will consist of 20 healthy participants. Each individual participant will rec...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening
• • A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
• • Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding
• • Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug
• • Be non-smoking for at least 3 months prior to selection.
• Exclusion Criteria:
• • Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication
• • Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day
• • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
• • Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.