22
Participants
Start Date
March 10, 2014
Primary Completion Date
October 7, 2015
Study Completion Date
October 7, 2015
GSK2330672
GSK2330672 oral preserved solution 1.5mg/g will be supplied in amber glass bottles and as per randomization schedule subject will receive 45 mg BID from Day 1 to 3 and 90 mg BID from Day 4 to 14 of one of the two treatment periods.
Placebo
Placebo oral preserved solution will be supplied in amber glass bottles and as per randomization schedule subject will receive placebo BID from Day 1 to 14 of one of the two treatment periods. .
Ursodeoxycholic acid
UDCA 250 mg will be supplied in capsule form. The subjects, who are taking UDCA at the time of Run-in-period, will be continued on the same total daily dose of drug but converted to a standardized formulation and a standardized dosing regimen administering the entire daily dose once daily in the evening before bedtime. Once daily dosing of UDCA will continue for the duration of the study.
GSK Investigational Site, Birmingham
GSK Investigational Site, Cambridge
GSK Investigational Site, Newcastle upon Tyne
Lead Sponsor
GlaxoSmithKline
INDUSTRY