NCT00449709

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
Last Updated

March 19, 2012

Status Verified

February 1, 2011

First QC Date

March 19, 2007

Last Update Submit

March 15, 2012

Conditions

Obstetric Labour, PrematurePremature Ejaculation

Keywords

Pre-term labor,modified release formulationpharmacokinetics,

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

GSK221149DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Premature BirthPremature Ejaculation

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEjaculatory DysfunctionGenital Diseases, MaleGenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

March 1, 2007

Last Updated

March 19, 2012

Record last verified: 2011-02

Locations

US(1)