A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

March 10, 2014

Primary Completion Date

October 7, 2015

Study Completion Date

October 7, 2015

Conditions
Cholestasis, Intrahepatic
Interventions
DRUG

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.

DRUG

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. .

DRUG

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.

Trial Locations (3)

B15 2WB

GSK Investigational Site, Birmingham

Unknown

GSK Investigational Site, Cambridge

NE1 4LP

GSK Investigational Site, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01899703 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus | Biotech Hunter | Biotech Hunter