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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
10 mg single oral dose. Each subject will receive 2 tablets of 5 mg GSK557296 four times a day (QID).
150 mg single oral dose. Each subject will receive multiple tablets of 25 mg GSK557296 either 2, 3 or 4 times a day.
Dose to be determined as a single dose tablet based on half-life demonstrated in Cohort 1 and Cohort 2.
Dose to be determined by PK of prior doses, based on half-life demonstrated in prior cohorts.
GSK Investigational Site
Baltimore, Maryland, United States
Composite of PK parameters of 20 mg GSK557296 following single and repeat oral dosing
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve \[AUC(0-t) and AUC(0-infinity)\], and apparent terminal phase half-life (t1/2). AUC(0-infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Time frame: 7 days
Composite of PK parameters of 150 mg GSK557296 following single and repeat oral dosing
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve \[AUC(0-t) and AUC(0-infinity)\], and apparent terminal phase half-life (t1/2). AUC(0- infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Time frame: 14 days
Safety and tolerability of GSK557296 following single and repeat dosing
Safety and tolerability parameters assessments include adverse events, clinical laboratory, ECG, vital signs, and concurrent medication
Time frame: up to 49 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.