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

GlaxoSmithKline1 site in 1 country36 target enrollmentMarch 2007

ConditionsObstetric Labour, Premature Premature Ejaculation

DrugsGSK221149

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Obstetric Labour, Premature
Sponsor: GlaxoSmithKline
Enrollment: 36
Locations: 1
Primary Endpoint: Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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

Outcomes

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.

Time Frame: 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..(over a 24 hour period during each study session.)