NCT01867996 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 11, 2013

Primary Completion Date

September 26, 2013

Study Completion Date

September 26, 2013

Conditions

Obstetric Labour, Premature

Interventions

DRUG

Retosiban

Retosiban will be supplied as clear colorless solution for infusion (300 mg in 20 mL via). Subject will receive loading dose of 6 mg over 5 min infusion followed by 6 mg/hour infusion for 12 hrs on Day 1 and Day 18.

DRUG

EFZ 600 mg

EZF 600 mg will be supplied as a yellow, capsular-shaped, film-coated tablet. Subjects will receive EFZ 600mg OD in the evening from Day 3 till Day 18.

Trial Locations (1)

21225

GSK Investigational Site, Baltimore