Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW273225 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence AB | EXPERIMENTAL | Subjects will be randomized to sequence AB, where A represents fasted state and B represents fed state. Subjects will be administered a single oral dose of GW273225 50 milligrams (mg) in the fasted state in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 2. There will be at least 21 days between doses for the fasted and fed treatment phases of the study. |
| Sequence BA | EXPERIMENTAL | Subjects will be randomized to sequence BA, where A represents fasted state and B represents fed state. Subjects will be orally administered a single dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg in the fasted state in dosing period 2. There will be at least 21 days between doses for the fed and fasted treatment phases of the study. |
| Name | Type | Description |
|---|---|---|
| GW273225 | DRUG | GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature. |
Inclusion Criteria: * Healthy male or female subjects aged 18-55 years, inclusive. * Body weight 45-100kg and BMI 19-29.9 kg/m2 inclusive. * Post-menopausal females (longer than two years). Or Pre-menopausal females with a documented hysterectomy and/or bilateral oophorectomy, the latter only when ...
GW273225 is an investigational small molecule being studied for the treatment of Bipolar Disorder. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use and is still being evaluated for safety and tolerability in early-stage trials.
GW273225 is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug candidate for the treatment of Bipolar Disorder.
GW273225 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for Bipolar Disorder, and its Phase 1 trial has been completed.
GW273225 has one completed clinical trial, registered as NCT00501865. This Phase 1 study assessed the effect of food on the concentration of GW273225 in the body of healthy male and female volunteers in the United Kingdom. The trial enrolled 14 participants.
GW273225 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Bipolar Disorder. The drug has not completed the clinical trial process required for regulatory approval and remains under study.