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Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00457925
First received: April 6, 2007
Last updated: March 15, 2012
Last verified: February 2011
  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
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
  Eligibility

Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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:
absorption,
metabolism,
excretion
distribution,

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

ClinicalTrials.gov processed this record on June 21, 2017