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COMPLETEDPHASE1

Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing

A Phase I Non-Randomized Multi Cohort, Open Label, Bridging Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing

NCT01669083•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This study will be the first dosing experience with this compound in women. It is important to characterize the pharmacokinetics of GSK557296 in women to determine the most appropriate doses and dosing regimens for future clinical studies. Understanding the pharmacokinetics of GSK557296 in women will also enable more accurate characterization of any exposure-response relationship in future studies. Two previous studies with GSK557296 were conducted in men with oral doses ranging from 10 milligram (mg) to 200 mg. GSK557296 is being studied in women for the indication of enhanced embryo and or blastocyst implantation in women undergoing IVF treatment. This is a bridging study to characterize the pharmacokinetics of GSK557296 in women to determine the most appropriate doses and dosing regimens for future clinical studies. This is a non-randomized, open label, adaptive design study in healthy female volunteers. A maximum total of 48 subjects, will participate in different cohorts. Subjects in Cohort 1 will receive 10 mg single dose followed by repeat dose. A one week break will occur to allow for analysis of the PK data, prior to starting the second Cohort. Subjects in Cohort 2 will receive 150 mg single dose followed by repeat dose. Cohort 3 and Cohort 4 were adaptive based on the requirement of additional doses to be studies after PK data will be analyzed from each of the first 2 cohorts.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5xupper limit of normal (ULN)
•Single or QTcF \< 450 millisecond (msec); or QTc \< 480 msec in subjects with Bundle Branch Block
•Healthy as determined by a responsible and experienced physician
•Female between 18 and 45 years of age inclusive, at the time of signing the informed consent
•A female subject is eligible to participate if she is of Child-bearing potential and is abstinent or agrees to use contraception methods to sufficiently minimize the risk of pregnancy during the study.
•Body weight \>= 50 kilogram (kg) and Body Mass Index (BMI) within the range 19 to 29.9 kg per meter\^2 (inclusive)

Exclusion Criteria

•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result at screening or within 3 months of screening
•Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
•A positive pre-study drug or alcohol screen
•A positive test for HIV antibody
•History of regular alcohol consumption within 6 months of the study
•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 Unable to refrain from the use of prescription or non-prescription drugs, with the exception of Oral contraceptives, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication 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 GSK Medical Monitor, contraindicates their participation
•Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56 day period
•Pregnant females
•Lactating females
•Unwillingness or inability to follow the procedures outlined in the protocol
+3 more criteria

Locations (1)

GSK Investigational Site

Baltimore, Maryland, United States

Key Dates

Start Date

August 16, 2012

Primary Completion Date

March 9, 2013

Completion Date

March 9, 2013

Last Updated

June 7, 2017

Enrollment

ACTUAL participants

Conditions

Embryo Transfer

Interventions

GSK557296 10 mg

DRUG

GSK557296 150 mg

DRUG

GSK557296 dose 3

DRUG

GSK557296 dose 4

DRUG

Transfer Direct System as a New Method for Embryo Transfer

NCT06744049

Embryo Transfer

View study

RECRUITINGPHASE4

Ketorolac Use and Fresh Embryo Transfer Outcomes

NCT07185724

Infertility (IVF Patients)Infertility Treatment+3 more

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Pharmacokinetics, Safety and Tolerability of GSK557296 in Healthy Women Volunteers After Single and Repeat Dosing

Inclusion Criteria

Exclusion Criteria

Transfer Direct System as a New Method for Embryo Transfer

Ketorolac Use and Fresh Embryo Transfer Outcomes

Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT)

Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer

Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols

Benefit of Amlodipine in HRT Cycle for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index