Absorption, Distribution, Metabolism And Excretion Study For GSK221149A - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00457925

Purpose

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

Condition	Intervention	Phase
Premature Labor	Drug: GSK221149A	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	6
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	30 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457925

Locations

United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53704

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OTA105101
Study First Received:	April 6, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00457925
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

absorption,
distribution,
metabolism,
excretion

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Healthy

ClinicalTrials.gov processed this record on January 14, 2009