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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00501865 | Study to Assess the Effect of Food on the Concentration of GW273225 in the Body of Healthy Male and Female Volunteers | PHASE1 | COMPLETED | 14 | — | — | Aug 6, 2007 | Oct 11, 2007 | Aug 4, 2017 | 1 | United Kingdom |
| 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 ...