drugset
drugset / Trial / NCT04950764

An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

NCT04950764 ↗

Phase 1 Completed 24 enrolled Gilead Sciences
Non-randomizedSequentialOpen-labelTreatment

Summary

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Timeline

Start
2021-11-16
Primary completion
2025-02-24
Completion
2025-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Seladelpar Small molecule 5 mg Oral
Subject Seladelpar Small molecule 10 mg Oral

Indications

primary biliary cholangitis