Clinical Trials Logo

Clinical Trial Summary

This will be a randomized single sequence open label study. This study is designed to determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and the total duration of study participation for each subject will be approximately 8 weeks. During the treatment period, subjects will be admitted to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min), followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days 3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus a 600 mg dose of EFZ.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01867996
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date June 11, 2013
Completion date September 26, 2013

See also
  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 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
Completed NCT01627587 - A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole Phase 1