NCT00457925

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
Last Updated

March 19, 2012

Status Verified

February 1, 2011

First QC Date

April 6, 2007

Last Update Submit

March 15, 2012

Conditions

Obstetric Labour, PrematurePremature Labor

Keywords

absorption,metabolism,excretiondistribution,

Outcome Measures

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.

Interventions

GSK221149ADRUG

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult, non-smoking females
  • Aged between 30 - 55 years old, and BMI of between 19 and 32
  • Not of child-bearing potential

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Interventions

GSK221149A

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2007

First Posted

April 9, 2007

Study Start

October 1, 2006

Last Updated

March 19, 2012

Record last verified: 2011-02

Locations

US(1)