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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449709

Enrollment

Registered

2007-03-21

Start date

2007-03-31

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labour, Premature, Premature Ejaculation

Keywords

Pre-term labor,, modified release formulation, pharmacokinetics,

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.

Interventions

DRUGGSK221149

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.	over a 24 hour period during each study session.

Secondary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026