Status:
COMPLETED
VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
Lead Sponsor:
Tibotec BVBA
Conditions:
Hepatitis C
HCV
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect of TVR on the ph...
Detailed Description
The trial will enroll 20 Healthy volunteers. All participants will receive 4 different treatments: Treatment A: TVR every 8 hours alone for 6 days with an additional morning intake on Day 7. Treatmen...
Eligibility Criteria
Inclusion
- Females should be post-menopausal (amenorrheal for at least 3 years), or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
- Normal weight at screening as defined by a body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
- Normal 12-lead ECG at screening
- Healthy on the basis of a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
- Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening.
Exclusion
- No history or presence of relevant drug or food allergies, cardiovascular or central nervous system disease, clinically significant pathology, mental disease or psychiatric disorders, chronic skin disease, or drug abuse
- Current use of prescription medication
- Regular treatment with over-the-counter medications
- Consumption of herbal medications or dietary supplements
- A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs
- Participation in a clinical study within 2 months or 5 half lives of the investigational drug prior to the screening visit
- No positive HIV test or hepatitis A, B or C infection
- Having any history of renal disease
- Male subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00828789
Start Date
February 1 2009
End Date
April 1 2009
Last Update
December 17 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.