Open-Label Study of Seladelpar

• Research type

  Research Study

• Full title

  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

• IRAS ID

  302371

• Contact name

  Michael Heneghan

• Contact email

  Michael.heneghan@nhs.net

• Sponsor organisation

  CymaBay Therapeutics, Inc.

• Eudract number

  2020-005925-10

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT04950764

• Duration of Study in the UK

  2 years, 0 months, 21 days

• Research summary

  A study of an investigational drug called seladelpar as a possible treatment for primary biliary cholangitis (PBC). The main purpose of this study, which involves research, is to learn how well the seladelpar is absorbed in the body and how safe the study drug is in participants with PBC presenting with different degree of abnormal liver function.
  Primary biliary cholangitis (PBC) is a chronic liver disease which results from progressive destruction of the bile ducts (tubes which carry bile) in the
  liver called the intrahepatic bile ducts. Bile produced in the liver travels via these ducts to small intestine and aids in digestion of fat and fat-soluble vitamins (A, D, E and K). In PBC when the ducts are destroyed, bile builds up in the liver and contributes to inflammation and scarring (fibrosis). This impaired bile-flow (cholestasis) and accumulation of toxic bile acids is one of the main
  characteristics of PBC. The most common symptoms of PBC are fatigue (feeling tired) and pruritus (itching). Successful treatment of PBC reduces the build-up of the bile in the liver and its associated symptoms. First treatment option for PBC is ursodeoxycholic acid; (UDCA) however, up to 40% of patients are considered inadequate responders. These patients can be treated with obeticholic acid, but some patients do not respond adequately or are intolerant to this medication. Therefore, additional treatments are needed for the long-term treatment of PBC.
  The drug being tested in this study is seladelpar. Other studies in PBC patients have shown that seladelpar may be useful for lowering disease associated biomarker alkaline phosphatase (ALP) levels and decreasing itching. Seladelpar has been tested previously in approximately 17 clinical studies and the results have been generally safe and well tolerated

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  21/EM/0264

• Date of REC Opinion

  31 Jan 2022

• REC opinion

  Further Information Favourable Opinion