Back to resultsAbsorption, Distribution, Metabolism And Excretion Study For GSK221149A
Primary Purpose
Obstetric Labour, Premature, Premature Labor
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK221149A
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Labour, Premature focused on measuring absorption,, metabolism,, excretion, distribution,
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457925
Brief Title
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labour, Premature, Premature Labor
Keywords
absorption,, metabolism,, excretion, distribution,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK221149A
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
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