Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

Phase 1

Completed

• Conditions: Obstetric Labour, Premature; Premature Labor

• Registration Number: NCT00457925
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-04-06
• Study First Submitted QC: 2007-04-06
• Study First Posted: 2007-04-09
• Status Verified: 2011-02
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and fecal samples for assessment of metabolites. Samples are collected for approximately 7 days (or longer).

Secondary Outcome Measures

Name	Time	Method
Clinical Safety data. PK parameters of GSK221149A and drug-related material (radioactivity) in plasma following oral and intravenous dosing. Samples are collected for approximately seven days (or longer) following dosing.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Madison, Wisconsin, United States