Trials / Completed
CompletedNCT02966834
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 147 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | GSK2330672 matching placebo will be supplied as white film-coated tablets. |
| DRUG | GSK2330672 | GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets. |
Timeline
- Start date
- 2017-01-11
- Primary completion
- 2020-04-15
- Completion
- 2020-04-15
- First posted
- 2016-11-17
- Last updated
- 2021-05-04
- Results posted
- 2021-05-04
Locations
66 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, Japan, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02966834. Inclusion in this directory is not an endorsement.