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 being studied for the treatment of premature obstetric labour. It is in Phase 1 clinical development and is not yet approved for any use.
GSK221149 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK.
GSK221149 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
GSK221149 has one completed Phase 1 trial, NCT01627587, which studied its metabolites, the effect of a high fat meal, and interaction with ketoconazole. The trial enrolled 46 female participants in the United States.
GSK221149 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials, and its safety and efficacy have not been established.