The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/17/2018 |
| Start Date: | October 12, 2007 |
| End Date: | July 7, 2011 |
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
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.
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.
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
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
Inclusion criteria:
- Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes
- 18-45 inclusive
- Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour,
each of which at least 30 sec in duration, with cervical dilatation of less than or
equal to 4 cm, (measured by tocodynamometry).
Exclusion criteria:
- Any clinically relevant abnormality identified on the screening examination or any
other medical condition or circumstance making the patient (mother and/or fetus)
unsuitable for participation in the study
- Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may
affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes
mellitus, bleeding/clotting diathesis)
We found this trial at
30
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials