A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)
Status:
Completed
Trial end date:
2013-09-26
Target enrollment:
Participant gender:
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.