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Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 6, 2007
Last updated: March 15, 2012
Last verified: February 2011
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
Obstetric Labour, Premature Premature Labor Drug: GSK221149A Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00457925

United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00457925     History of Changes
Other Study ID Numbers: OTA105101
Study First Received: April 6, 2007
Last Updated: March 15, 2012

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on June 21, 2017