VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
Primary Purpose
Hepatitis C, HCV, HIV
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Efavirenz; Tenofovir disoproxil fumarate; Telaprevir
Sponsored by

About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, HCV, HIV, AIDS, Telaprevir, Efavirenz, Tenofovir disproxil fumarate, Healthy volunteer, VX-950-C134, VX-950-TiDP24-C134, HIV Infections
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary objectives are to determine the effect of EFV and TDF on the pharmacokinetics of TVR and VRT-127394 and of TVR every 8h and every 12h on the pharmacokinetics of EFV and TDF.
Secondary Outcome Measures
The secondary objective is to determine the short-term safety and tolerability of the coadministration of TVR, EFV and TDF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00828789
Brief Title
VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
Official Title
A Phase I, Open-label, Randomized, Crossover Trial in 20 Healthy Subjects to Investigate the Pharmacokinetic Interactions Between the Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tibotec BVBA
4. Oversight
5. Study Description
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 pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will be evaluated.
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. Treatment B: EFV + TDF once daily alone for 7 days. Treatment C: TVR every 8 hours + EFV once daily + TDF once daily for 7 days. Treatment D: TVR every 12 hours + EFV once daily + TDF once daily for 7 days.
All participants will start with Treatment A followed by a 7 or 8-day washout period. Subsequently, participants will start with Treatment B. At the end of Treatment B, participants will be randomized (this is assigned to one of the two sequences by chance) to continue without a washout period with Sequence 1 (Treatment C followed by D without a washout) or Sequence 2 (Treatment D followed by C without a washout). Participants will thus receive daily EFV and TDF for a total of 21 consecutive days, with addition of 2 different dosages of TVR for the last 14 days.
TVR will be taken with food, 30 minutes after the start of a meal. EFV and TDF should be taken on an empty stomach (2.5 hours after start of breakfast). Pharmacokinetic profiles of TVR and VRT-127394 (R-diastereomer of TVR) will be measured up to 8 hours after intake of the morning dose on Day 7 of Treatments A and C, and up to 12 hours after intake of the morning dose on Day 7 of Treatment D. Pharmacokinetic profiles of EFV and tenofovir will be measured up to 24 hours after intake on Day 7 of Treatments B, C, and D. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial period. Treatment A: TVR every 8 hours alone for 6 days with an additional morning intake on Day 7. Treatment B: EFV + TDF once daily alone for 7 days. Treatment C: TVR every 8 hours + EFV once daily + TDF once daily for 7 days. Treatment D: TVR every 12 hours + EFV once daily + TDF once daily for 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HCV, HIV, AIDS
Keywords
Hepatitis C, HCV, HIV, AIDS, Telaprevir, Efavirenz, Tenofovir disproxil fumarate, Healthy volunteer, VX-950-C134, VX-950-TiDP24-C134, HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Efavirenz; Tenofovir disoproxil fumarate; Telaprevir
Primary Outcome Measure Information:
Title
The primary objectives are to determine the effect of EFV and TDF on the pharmacokinetics of TVR and VRT-127394 and of TVR every 8h and every 12h on the pharmacokinetics of EFV and TDF.
Secondary Outcome Measure Information:
Title
The secondary objective is to determine the short-term safety and tolerability of the coadministration of TVR, EFV and TDF.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibotec-Virco Virology BVBA Clinical Trial
Organizational Affiliation
Tibotec BVBA
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer
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