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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|ClinicalTrials.gov Identifier: NCT00828789|
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : December 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C HCV HIV AIDS||Drug: Efavirenz; Tenofovir disoproxil fumarate; Telaprevir||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2009|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
- 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.
- The secondary objective is to determine the short-term safety and tolerability of the coadministration of TVR, EFV and TDF.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828789
|Study Director:||Tibotec-Virco Virology BVBA Clinical Trial||Tibotec BVBA|