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NCT00457925 Clinical Trial

Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

Premature Labor Clinical Trial

Official title:
An Open-label, Two Period Study to Determine the Excretion Balance and Pharmacokinetics of [14C]-GSK221149A, Administered as Single Doses of an Oral Solution and an Intravenous Infusion to Healthy Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00457925
Other study ID # OTA105101
Secondary ID
Status Completed
Phase Phase 1
First received April 6, 2007
Last updated March 15, 2012
Start date October 2006

Study information
Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 55 Years
Eligibility Inclusion criteria:

- Healthy adult, non-smoking females

- Aged between 30 - 55 years old, and BMI of between 19 and 32

- Not of child-bearing potential

Exclusion criteria:

- No clinically significant findings on clinical examination, medical examination and blood tests.

- Radiation exposure over previous 3 years is greater than 10mSv

- History of bleeding or gastric problems

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GSK221149A

Locations
Country Name City State
United States GSK Investigational Site Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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.
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