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COMPLETED
NCT05112939
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

DRUG

RPV LA

RPV LA will be administered at different formulations.

DRUG

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