Back to resultsA Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
Primary Purpose
Obstetric Labour, Premature, Premature Ejaculation
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK221149
Sponsored by
About this trial
This is an interventional treatment trial for Obstetric Labour, Premature focused on measuring Pre-term labor,, modified release formulation, pharmacokinetics,
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
Secondary Outcome Measures
Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00449709
Brief Title
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Terminated
Study Start Date
March 2007 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labour, Premature, Premature Ejaculation
Keywords
Pre-term labor,, modified release formulation, pharmacokinetics,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK221149
Primary Outcome Measure Information:
Title
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
Time Frame
over a 24 hour period during each study session.
Secondary Outcome Measure Information:
Title
Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..
Time Frame
over a 24 hour period during each study session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
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A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
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