Finding studies
Finding studies
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Lead
Tibotec BVBA
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.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
