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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

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