Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Epelsiban in Healthy Female Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Embryo Transfer
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
Epelsiban is a potent and selective oxytocin receptor antagonist in development for enhanced implantation rates during in-vitro fertilization (IVF). This study a non-randomized, open label study desig...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Females between 18 and 55 years of age inclusive, at the time of consent.
- Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, review of medications previously used, physical examination, laboratory tests and ECG.
- Body mass index (BMI) within the range 18-35 kilogram per square meter( kg/m\^2) (inclusive).
- Female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin \[hCG\] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential or postmenopausal.
- Exclusion Criteria
- Alanine Transferase (ALT) and bilirubin \>1.5x upper limit of normal(ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT (QTc) \> 450 milliseconds (msec). - History of regular alcohol consumption within 3 months of dosing on Day 1 defined as: an average weekly intake of \>7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 milliliter \[mL\]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of Study Treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core antibody (HBcAb) should also be excluded.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Exclusion
Key Trial Info
Start Date :
December 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02257359
Start Date
December 18 2014
End Date
January 29 2015
Last Update
September 13 2018
Active Locations (1)
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1
GSK Investigational Site
Overland Park, Kansas, United States, 66211