Last updated: 11/04/2018 10:08:12
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A two-part, open-label, cross-over study to assess the pharmacokinetics of GSK221149 following single oral doses of various modified release formulations and a solution in healthy adult subjects
Trial description: PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
Timeframe: over a 24 hour period during each study session.
Secondary outcomes:
Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..
Timeframe: over a 24 hour period during each study session.
Interventions:
Enrollment:
36
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Obstetric Labour, Premature, Premature Ejaculation
Product
retosiban
Collaborators
Not applicable
Study date(s)
March 2007 to May 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- Healthy males and non-pregnant female
- Between the ages of 18 and 50 years old.
- History of smoking within past 6 months
- Regular alcohol consumption averaging 7 drinks or more per week
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy males and non-pregnant female
- Between the ages of 18 and 50 years old.
- Females may be of child-bearing or non-child-bearing potential.
- Non-smokers
- BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs).
Exclusion criteria:
- History of smoking within past 6 months
- Regular alcohol consumption averaging 7 drinks or more per week
- Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV
- Use of prescription or non-prescription drugs within 14 days of study start
Trial location(s)
Location
GSK Investigational Site
TACOMA, Washington, United States, 98418
Status
Terminated/Withdrawn
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
Other
Actual primary completion date
Not applicable
Actual study completion date
2007-13-05
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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