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Cabotegravir IR Formulation · 1 trial · 1 indication
| 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...
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Cabotegravir IR Formulation is an investigational small molecule being studied for the treatment of HIV Infections. It is an immediate-release formulation of cabotegravir, an integrase inhibitor, and is currently in Phase 1 clinical development. The drug is being evaluated for its pharmacokinetic profile and food effect in healthy volunteers.
Cabotegravir IR Formulation is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to assess the drug's bioavailability and food effect in the context of HIV treatment.
Cabotegravir IR Formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate the food effect and relative bioavailability of the pediatric dispersible tablet formulation.
Cabotegravir IR Formulation has one completed Phase 1 clinical trial, NCT05776108, titled 'A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation.' The trial enrolled 24 participants in the United States and was a controlled, randomized study in healthy volunteers.
Cabotegravir IR Formulation is an immediate-release (IR) formulation of cabotegravir, an integrase inhibitor used in HIV treatment. While the active ingredient is the same, the IR formulation is distinct from other formulations, such as the pediatric dispersible tablet, and is being studied separately in early-phase trials.