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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05776108 | A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation | PHASE1 | COMPLETED | 24 | — | — | Mar 23, 2023 | Jun 8, 2023 | Dec 13, 2023 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2) | EXPERIMENTAL | Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment . |
| CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2) | EXPERIMENTAL | Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment. |
| CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1) | EXPERIMENTAL | Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment. |
| CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1) | EXPERIMENTAL | Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment. |
| CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference) | EXPERIMENTAL | Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment. |
| CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference) | EXPERIMENTAL | Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment. |
| Name | Type | Description |
|---|---|---|
| Cabotegravir IR Formulation (reference) | DRUG | Cabotegravir IR Formulation (reference) will be administered. |
| Cabotegravir DT Formulation (test 1) | DRUG | Cabotegravir DT Formulation (test 1) will be administered. |
| Cabotegravir DT Formulation (test 2) | DRUG | Cabotegravir DT Formulation (test 2) will be administered. |
Inclusion criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF). * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical exami...