Last updated: 11/04/2018 10:07:21
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK221149A
Enrollment:
6
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Obstetric Labour, Premature
Product
retosiban
Collaborators
Not applicable
Study date(s)
October 2006 to December 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
30 - 55 years
Accepts healthy volunteers
Yes
- Healthy adult, non-smoking females
- Aged between 30 - 55 years old, and BMI of between 19 and 32
- No clinically significant findings on clinical examination, medical examination and blood tests.
- Radiation exposure over previous 3 years is greater than 10mSv
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
MADISON, Wisconsin, United States, 53704
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-29-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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