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Also known as TMC278
RPV LA · 1 trial · 1 indication
Plasma samples will be analyzed to determine concentrations of RPV using a validated, specific, and sensitive method.
Plasma samples will be analyzed to determine concentrations of CAB using a validated, specific, and sensitive method.
| Arm | Type | Description |
|---|---|---|
| Panel A: Rilpivirine (RPV) Long-acting (LA) | EXPERIMENTAL | Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment A and B) on Day 1. |
| Panel B: RPV LA | EXPERIMENTAL | Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment C and D) on Day 1. |
| Panel C: RPV LA | EXPERIMENTAL | Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment E and F) on Day 1, based on interim data of Panel A. |
| Panel D: RPV LA | EXPERIMENTAL | Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment G and H) on Day 1, based on interim data of Panel B. |
| Panel E: RPV LA + Cabotegravir (CAB) LA | EXPERIMENTAL | Participants will receive one dose of RPV LA (formulation 1) with CAB LA (formulation 3) (Treatment I) on Day 1. |
| Name | Type | Description |
|---|---|---|
| RPV LA | DRUG | RPV LA will be administered at different formulations. |
| CAB LA | DRUG | CAB LA will be administered at formulation 3. |
Inclusion Criteria: * Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (based on the average value of triplicate ECGs) performed at screening (results must be available on Day -1) * Participant must be healthy on the...
RPV LA is an investigational long-acting injectable formulation of rilpivirine, a small molecule developed by Johnson & Johnson. It is being studied as an extended-release suspension, and its specific therapeutic indications have not been disclosed. It remains in clinical development and is not approved for any use.
RPV LA is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor behind the clinical program evaluating this long-acting injectable formulation.
RPV LA is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational, and the drug has not been approved by the FDA or any other regulatory agency.
RPV LA has been evaluated in one completed Phase 1 trial, NCT05112939, titled A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants. The trial enrolled 126 healthy volunteers across the United States and the Netherlands and used a controlled, randomized design without double blinding.
RPV LA is a long-acting extended-release formulation of rilpivirine, so it contains the same active small molecule. The LA designation refers to the injectable depot version designed for extended release, distinguishing it from other formulations of rilpivirine.