Status:
COMPLETED
VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir
Lead Sponsor:
Tibotec BVBA
Collaborating Sponsors:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chroni...
Detailed Description
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 seq...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01253551
Start Date
December 1 2010
End Date
April 1 2011
Last Update
October 16 2012
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