Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
Status:
Completed
Trial end date:
2020-04-15
Target enrollment:
Participant gender:
Summary
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672
administration for the treatment of pruritus (itch) in participants with primary biliary
cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of
GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily).
Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study
has a prospectively defined adaptive design that will utilize interim data to further inform
and potentially optimize the doses under investigation. Hence, additional dose regimen may be
added during study. The total duration of a participant in the study will be up to 45 days of
screening and 24 weeks of study including follow-up.