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

Stopped early · Phase 1

Conditions studied: Obstetric Labour, Premature, Premature Ejaculation

In brief

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.

Key facts

Study ID

NCT00449709

Run by

GlaxoSmithKline

People needed

36

Starts

2007-03-01

Last updated by the study team

2012-03-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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