A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and the pharmacokinetics of GSK221149A administered orally to healthy, pregnant females with uncomplicated pre-term labor between 34 0/7 and 35 6/7 weeks gestatio

• Conditions: ncomplicated preterm labour; MedDRA version: 8.1Level: LLTClassification code 10023555Term: Labour premature

• Registration Number: EUCTR2006-005807-32-LT
• Lead Sponsor: GlaxoSmithKline Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-06
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 79

Inclusion Criteria

1. Aged at least 18 years
2. 340/7 -356/7 weeks (best obstetric estimate, preferably first trimester ultrasound) with singleton pregnancy
3. Symptoms of pre-term labor: =6 uterine contractions per hour, each of at least 30 sec in duration with cervical dilatation =3cm, as measured by tocodynamometry
4. Intact fetal membranes
5. Positive cervicovaginal fetal fibronectin test and/or ultrasonographic cervical length =20mm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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
2. 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)
3. Known fetal intrauterine growth restriction or fetal congenital anomaly
4. Abnormal modified biophysical profile (NST is non-reactive and AFI <5)
5. Participation in another clinical trial during the current pregnancy
6. Abuse of alcohol, defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits, or 1 glass (125mL of wine).
7. History of anaphylaxis or anaphylactoid reactions, severe allergic responses to drugs
8. Known to be positive for hepatitis C antibody, hepatitis B surface antigen or HIV on prenatal labs
9. Use of any prescription drugs (other than prenatal vitamins, beta-lactam antibiotics or antenatal steroids) within 7 days or 5 half-lives (whichever is longer) prior to first dose of medication
10. Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng, and red yeast rice (2-fold greater than the recommended daily allowance) within 14 days prior to first dose of medication
11. Consumption of grapefruit or grapefruit juice within 3 days prior to first dose of medication
12. QTc > 450 msec (either QTcb or QTcf, machine or manual overread, on single or average QTc value of triplicate ECGs obtained over a brief recording period.)
13. QTc > 480 msec for patients with Bundle Branch Block
14. Use of illicit drugs or positive urine drug screen during pregnancy
15. Any tocolytic therapy within 24 hours
16. Any contraindication to tocolytic therapy, including (but not limited to) suspected intrauterine infection, vaginal bleeding, pre-eclampsia/eclampsia
17. Trauma within 48 hours of presentation in preterm labor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified