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Also known as Cabotegravir IR Formulation (reference)
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...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Cabotegravir IR Formulation is an immediate-release oral small molecule developed by GSK plc for HIV infections. It is an investigational pediatric dispersible tablet formulation studied in a Phase 1 trial to assess food effects and relative bioavailability. It is not an approved product and remains in clinical development.
Cabotegravir IR Formulation is being developed for the treatment or prevention of HIV infections. The Phase 1 study enrolled healthy adult volunteers to evaluate the pediatric dispersible tablet formulation, not to test efficacy in patients. Its intended use in HIV care has not been established through late-stage trials.
Cabotegravir IR Formulation is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 trial evaluating this immediate-release pediatric dispersible tablet formulation of cabotegravir for HIV infections.
Cabotegravir IR Formulation is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any regulatory authority for any indication.
Cabotegravir IR Formulation has been studied in one completed Phase 1 trial, NCT05776108. The trial assessed food effects and relative bioavailability of the cabotegravir pediatric dispersible tablet formulation in 24 healthy adult volunteers in the United States. It was randomized and controlled but not double-blind.
Yes, Cabotegravir IR Formulation is also known as Cabotegravir IR Formulation (reference). Both names refer to the same immediate-release oral small molecule developed by GSK plc for HIV infections, currently in Phase 1 development.