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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-06-15

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627587 on ClinicalTrials.gov