Obstetric Labour, Premature Clinical Trial
Official title:
A Two Cohort, Open-label Study to Evaluate the Pharmacokinetics of GSK2847065, the Metabolite of Retosiban (GSK221149) After Single and Repeat Oral Doses, the Pharmacokinetics of GSK221149 Coadministered With a High Fat Meal, and the Pharmacokinetics of GSK221149 Coadministered With an Inhibitor of CYP3A4 (Ketoconazole)
This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study will look at the pharmacokinetics of GSK221149 following a high fat meal.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01702376 -
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
|
Phase 1 | |
Completed |
NCT00549211 -
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
|
Phase 1 | |
Completed |
NCT00457925 -
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
|
Phase 1 | |
Completed |
NCT00404768 -
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
|
Phase 2 | |
Terminated |
NCT00449709 -
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT02377414 -
Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women
|
Phase 1 | |
Terminated |
NCT02292771 -
A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
|
Phase 3 | |
Completed |
NCT01867996 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)
|
Phase 1 | |
Completed |
NCT02292784 -
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
|
Phase 3 | |
Terminated |
NCT02377466 -
A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
|
Phase 3 |