Skip to main content
OpenTrials
Completed

NCT Number: NCT00457925

Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstetric Labour, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Labor Urogenital Diseases

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK221149A

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Apr 9, 2007
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.