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

NCT05112939 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-05-12

No results posted yet for this study

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

DRUG

RPV LA

RPV LA will be administered at different formulations.

DRUG

CAB LA

CAB LA will be administered at formulation 3.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2024-05-23
Completion
2024-05-23
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05112939 on ClinicalTrials.gov