Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK2248761 WBM Capsule, GSK2248761 WBM Tablet Formulation 1, GSK2248761 WBM Formulation 1, GSK2248761 WBM Tablet Formulation 2, GSK2248761 WBM Formulation 2, GSK2248761 WBM Tablet Formulation 3, GSK2248761 WBM Formulation 3
GSK2248761 WBM · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Periods 1 - 4 | EXPERIMENTAL | Subjects will be randomized in a cross over fashion to receive the GSK2248761 WBM capsule formulation or one of three WBM tablet formulations in one of four sequences. |
| Period 5 | EXPERIMENTAL | Subjects in Part B will receive a formulation of GSK2248761 200mg WBM Tablet chosen from Periods 1 - 4 in part A in the fed state (moderate fat meal). |
| Name | Type | Description |
|---|---|---|
| GSK2248761 WBM Capsule | DRUG | 200 mg GSK2248761 WBM capsule (reference) 2 X100mg |
| GSK2248761 WBM Tablet Formulation 1 | DRUG | GSK2248761 WBM Tablet 200mg manufacturing process 1 |
| GSK2248761 WBM Tablet Formulation 2 | DRUG | GSK2248761 WBM Tablet 200mg manufacturing process 2 |
| GSK2248761 WBM Tablet Formulation 3 | DRUG | GSK2248761 WBM Tablet 200mg manufacturing process 3 |
| GSK2248761 WBM Tablet | DRUG | GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4 |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range ...
GSK2248761 WBM is an investigational small molecule developed by GSK plc for infectious disease indications, specifically Human Immunodeficiency Virus and Herpesviridae infections. It is a Phase 1 candidate and has not been approved for any use. The WBM designation refers to the tablet and capsule formulations studied in a bioavailability trial.
GSK2248761 WBM is being studied for the treatment of infections, including Human Immunodeficiency Virus and Herpesviridae. It remains investigational and is not approved for any indication. Its only recorded clinical trial enrolled healthy adult volunteers rather than patients, so no efficacy in these infections has been established.
GSK2248761 WBM is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 bioavailability study of the drug's tablet formulations conducted in the United States.
GSK2248761 WBM is in Phase 1 development. It is investigational and has not received FDA approval. One Phase 1 trial has been completed, and no trials are currently active.
GSK2248761 WBM has been evaluated in one completed Phase 1 trial, NCT01209117, titled a study to assess the relative bioavailability of tablet formulations of GSK2248761 in healthy adult subjects. The randomized, controlled study enrolled 24 healthy volunteers aged 18 years and older in the United States.
Yes. GSK2248761 WBM Formulation 1, Formulation 2, and Formulation 3, along with the corresponding tablet and capsule formulation names, all refer to the same drug, GSK2248761 WBM. These names describe the different oral formulations compared in the Phase 1 bioavailability study.