drugset / Trial / NCT04024813
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
Timeline
- Start
- 2019-11-12
- Primary completion
- 2020-01-09
- Completion
- 2020-01-09
Outcome
Outcome not reported
Stopped: “Study was terminated as a precautionary measure due to histological findings in a nonalcoholic steatohepatitis (NASH) study (CB8025-21730, NCT03551522).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Seladelpar | Small molecule | 5 mg | Oral |
| Subject | Seladelpar | Small molecule | 10 mg | Oral |
| Subject | Seladelpar | Small molecule | 25 mg | Oral |