Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457925
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Obstetric Labour, Premature Premature Labor Drug: GSK221149A Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457925

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

Responsible Party: GlaxoSmithKline Identifier: NCT00457925     History of Changes
Other Study ID Numbers: OTA105101
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications