Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05112939 | A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants | PHASE1 | COMPLETED | 126 | — | — | Nov 16, 2021 | May 23, 2024 | May 12, 2026 | 3 | United States, Netherlands |
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...