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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstetric Labour, Premature Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GSK221149

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes