drugset / Trial / 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

NCT01627587

Phase 1 Completed 46 enrolled GlaxoSmithKline
RandomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2011-12-12
Primary completion
2012-02-09
Completion
2012-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Retosiban Small molecule 100 mg Oral
Subject Retosiban Small molecule 750 mg Oral
Background Ketoconazole Small molecule 400 mg

Indications