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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

Clinical Trial Details

This study ia evaluating the safety and efficacy of the study drug seladelpar in people with Primary Biliary Cholangitis (PBC) and abnormal liver function. This will be done by looking at how the study drug seladelpar affects PBC and observing changes in the laboratory tests that are used to monitor the severity of PBC and its prognosis.

PBC is a chronic disease of the liver resulting from progressive destruction of bile ducts in the liver. Bile is a substance produced by the liver to facilitate digestion. With PBC, the bile ducts develop inflammation and causes liver damage, which may eventually lead to cirrhosis (liver scarring).

Seladelpar is being developed to reduce PBC and is considered to be experimental/investigational, meaning it is not approved by the U.S. Food and Drug Administration (FDA).

All study participants will receive 10 mg tablets of seladelpar.

Participation in this study will last for up to 12 weeks and participants will be compensated for their time.

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with Primary Biliary Cholangitis (PBC) and abnormal liver function.

 Detailed eligibility reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

GI/ Hepatology
(646) 962-4040
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2305026014

ClinicalTrials.gov:

NCT04950764

Sponsor:

CB8025-21838

Status

Open to Enrollment

Age Group

Adult

Sponsor