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A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with cabotegravir (CAB) LA extended release suspensions in different conditions in healthy adult participants.
Official title: A Phase 1, Single-blind, Randomized, Parallel-group Study in Healthy Participants to Investigate the Single-dose Pharmacokinetics, Safety and Tolerability of Rilpivirine After Subcutaneous Administration of a Rilpivirine Extended-Release Suspension Alone, and of Rilpivirine and Cabotegravir After Co-administration With Cabotegravir Extended-Release Suspension
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2021-11-16
Completion Date
2024-05-23
Last Updated
2026-05-12
Healthy Volunteers
Yes
Conditions
Interventions
RPV LA
RPV LA will be administered at different formulations.
CAB LA
CAB LA will be administered at formulation 3.
Locations (3)
PRA Health Sciences 2
Lenexa, Kansas, United States
PRA Health Sciences 1
Salt Lake City, Utah, United States
PRA Health Sciences
Groningen, Netherlands