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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Obstetric Labour, Premature

Interventions

Type	Name	Description
DRUG	GSK221149 750 mg	Treatment A: 750 mg GSK221149 single dose
DRUG	Ketoconazole	Treatment B: 400 mg of Ketoconazole single dose
DRUG	GSK221149 100 mg	Treatment C: 100mg of GSK221149 single dose
DRUG	GSK221149 750 mg Fasted	Treatment D: 750 mg of GSK221149 administered fasted
DRUG	GSK221149 750 mg + Food	Treatment E: 750 mg of GSK221149 administered with a high fat meal

Timeline

• Start date: 2011-12-12
• Primary completion: 2012-02-09
• Completion: 2012-02-09
• First posted: 2012-06-26
• Last updated: 2017-06-15

Locations

1 site across 1 country: United States