Human Immunodeficiency Virus Type 1 Clinical Trial
Official title:
A Phase 1 Open‐Label, Randomized, Parallel‐Group Study in Healthy Subjects to Investigate the Effect of Different Storage Conditions of a Long‐Acting Nanosuspension of Rilpivirine on the Single‐Dose Plasma Pharmacokinetics of Rilpivirine After Intramuscular Injection
The purpose of this study is to compare the single‐dose pharmacokinetics of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long‐acting parenteral formulation (RPV‐LA) and 'aged' RPV‐LA, in healthy adult participants.
This is a phase 1 randomized (study medication is assigned by chance), open‐label (all people know the identity of the intervention), parallel‐group, sequential study in healthy adult participants to investigate the effect of different storage conditions for RPV‐LA on the single‐dose pharmacokinetics of rilpivirine (RPV) after intramuscular injection. A total of 60 healthy adult participants will be enrolled in this study. The study will consist of 2 treatment sessions in a fixed sequential order : session 1 of up to day 8, all participants will receive a single oral dose of rilpivirine 25 milligram (mg) tablet on day 1, session 2 will consists of 2 treatment groups. The participants will be randomized in session 2 on Day 1 in a 1:1 ratio to Treatments A and B. Each treatment group will receive one IM injection of RPV LA on Day 1 of session 2. Session 1 and 2 will be separated by a washout period of at least 14 days. The total study duration for each participant will be approximately 6.5 months. Safety will be monitored throughout the study. ;
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