NCT04950764

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Primary Biliary Cholangitis
• Compensated Cirrhosis
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Seladelpar 10 mg	Seladelpar 10 mg single oral dose
DRUG	Seladelpar 10 mg or less	Seladelpar 10 mg or less, once daily for 28 days

Timeline

• Start date: 2021-09-17
• Primary completion: 2025-02-24
• Completion: 2025-02-27
• First posted: 2021-07-06
• Last updated: 2025-03-17

Locations

20 sites across 4 countries: United States, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study