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

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 1

Conditions

Obstetric Labour, Premature

Premature Ejaculation

Treatments

Drug: GSK221149

Study type

Interventional

Funder types

Industry

Identifiers

NCT00449709

OTA106004

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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