Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK221149 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ketoconazole-Part A | EXPERIMENTAL | Healthy Female volunteers of child bearing potential will receive Treatment A, B and C |
| Food-Part B | EXPERIMENTAL | Healthy Female Volunteers of child bearing potential will receive Treament D and E |
| Name | Type | Description |
|---|---|---|
| GSK221149 750 mg | DRUG | Treatment A: 750 mg GSK221149 single dose |
| Ketoconazole | DRUG | Treatment B: 400 mg of Ketoconazole single dose |
| GSK221149 100 mg | DRUG | Treatment C: 100mg of GSK221149 single dose |
| GSK221149 750 mg Fasted | DRUG | Treatment D: 750 mg of GSK221149 administered fasted |
| GSK221149 750 mg + Food | DRUG | Treatment E: 750 mg of GSK221149 administered with a high fat meal |
Inclusion Criteria: * ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%). * Single \[QTc, QTcB or QTcF\] less than 450 msec; or QTc less than 480 msec in subjects with Bu...
GSK221149 is an investigational small molecule developed by GSK plc for premature obstetric labour, the condition of preterm labour during pregnancy. It has been studied in a Phase 1 clinical trial in healthy adult female volunteers. GSK221149 is not approved and remains in clinical development.
GSK221149 was studied for premature obstetric labour, also called preterm labour, in which uterine contractions begin before term. The research was conducted in healthy female volunteers rather than in patients with active preterm labour. GSK221149 is investigational and has not been approved for any use.
GSK221149 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 study of the compound. GSK plc is the sole developer named for this asset.
GSK221149 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator for premature obstetric labour or any other indication.
GSK221149 has been evaluated in one completed Phase 1 trial, NCT01627587, titled a two cohort study looking at the metabolites of GSK221149, its metabolism when given with a high fat meal, and when given with ketoconazole. The trial enrolled 46 healthy female volunteers aged 18 years and older in the United States.