Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule being studied for use in healthy participants. It is a long-acting extended-release suspension formulation of rilpivirine. As of the available data, it is in Phase 1 clinical development and is not approved for any indication.
RPV LA is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development.
RPV LA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
RPV LA has one completed Phase 1 clinical trial, identified as NCT05112939. This study, titled 'A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants,' enrolled 126 participants in the United States and the Netherlands. The trial was controlled but not double-blinded.
RPV LA is a long-acting extended-release suspension formulation of rilpivirine. While rilpivirine is the active pharmaceutical ingredient, RPV LA refers specifically to this extended-release version being studied for its pharmacokinetic profile in healthy participants.