A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects

Phase 1

Terminated

• Conditions: Obstetric Labour, Premature; Premature Ejaculation

• Registration Number: NCT00449709
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-21
• Status Verified: 2011-02
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.	over a 24 hour period during each study session.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..	over a 24 hour period during each study session.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Tacoma, Washington, United States