NCT05112939

A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RPV LA	RPV LA will be administered at different formulations.
DRUG	CAB LA	CAB LA will be administered at formulation 3.

Timeline

• Start date: 2021-11-16
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2021-11-09
• Last updated: 2025-02-28

Locations

3 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study