The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Public ClinicalTrials.gov record NCT00404768. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK221149A Administered Intravenously and to Investigate the Pharmacokinetics of GSK221149A Administered Orally to Healthy, Pregnant Females With Uncomplicated Pre-term Labor Between 300/7 and 356/7 Weeks' Gestation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Pre-Term 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. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
Study identification
- NCT ID
- NCT00404768
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 93 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 12, 2007 (Actual)
- Primary completion
- Jul 7, 2011 (Actual)
- Completion
- Jul 7, 2011 (Actual)
- Last update posted
- Jan 16, 2018
2007 – 2011
United States locations
- U.S. sites
- 32
- U.S. states
- 19
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36604 | — |
| GSK Investigational Site | Phoenix | Arizona | 85008 | — |
| GSK Investigational Site | Phoenix | Arizona | 85013 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Colton | California | 92324 | — |
| GSK Investigational Site | Loma Linda | California | 92350 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Newark | Delaware | 19718 | — |
| GSK Investigational Site | Idaho Falls | Idaho | 83404 | — |
| GSK Investigational Site | Kansas City | Kansas | 66160 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55454 | — |
| GSK Investigational Site | St Louis | Missouri | 63023 | — |
| GSK Investigational Site | Newark | New Jersey | 07101-1709 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | — |
| GSK Investigational Site | Southern Pines | North Carolina | 28388 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45267 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425 | — |
| GSK Investigational Site | Columbia | South Carolina | 29201 | — |
| GSK Investigational Site | Chattanooga | Tennessee | 37403 | — |
| GSK Investigational Site | Knoxville | Tennessee | 37920-1511 | — |
| GSK Investigational Site | Memphis | Tennessee | 38119 | — |
| GSK Investigational Site | Galveston | Texas | 77555-0587 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Houston | Texas | 77054 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84124 | — |
| GSK Investigational Site | West Jordan | Utah | 84088 | — |
| GSK Investigational Site | Norfolk | Virginia | 23507-1914 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00404768, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 16, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00404768 live on ClinicalTrials.gov.