Hepatic Impairment Clinical Trial
Official 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
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)
Status | Recruiting |
Enrollment | 24 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Males and females between 18 and 80 years of age (inclusive) who are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF) 2. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use the contraceptive methods throughout the study and for 30 days after study drug administration. 3. For at least 90 days after study drug administration, non-vasectomized males must not donate sperm, be willing to use contraception with childbearing potential partners and any male subject with a pregnant partner must use a condom. 4. Willing to abstain from consuming grapefruit, pomelo, star fruit, or Seville orange containing products from 7 days prior to dose of study medication through day of discharge. 5. Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C 6. Screening laboratory parameters: - ALP, ALT and AST < 10 × ULN - Total bilirubin = 5 × ULN 7. Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1 8. At screening confirmed diagnosis of PBC 9. MELD-Na scores of 6 to 24 Exclusion Criteria: 1. Clinically significant or history of acute or chronic liver disease of an etiology other than PBC 2. Patients with a diagnosis of overlapping PBC and autoimmune hepatitis 3. History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms. 4. Presumptive or diagnosed infection that requires systemic therapy within 12 weeks of Screening and through Day 1 5. Female subjects who are pregnant or nursing 6. Screening ECG that demonstrates a QT interval = 500 msec, or any other significant ECG finding with clinically significant abnormalities as determined by the Investigator 7. Positive for HBsAg, HCV RNA, or anti HIV antibody 8. Any non-hepatic acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in the study or compromise the integrity of the data 9. Has experienced an illness that is considered by the Investigator to be clinically significant within 2 weeks before administration of investigational product 10. Clinically relevant drug or alcohol abuse within 6 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication 11. Use of obeticholic acid (OCA), any drug of the same class, or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) within 30 days of Baseline 12. Use of an experimental or unapproved treatment for PBC within 30 days of Baseline 13. Clinically evident complication(s) of cirrhosis and portal hypertension that required either emergency room visit, hospital admission or both during the 12 week period prior to investigational product administration |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | Korea - Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital Yonsei University Health System | Seoul | |
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
United Kingdom | University Hopsitals Birmingham | Birmingham | |
United Kingdom | King's College NHS Foundation Trust | London | |
United Kingdom | The Royal Free London NHS Foundation Trust | London | |
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | The Institute of Liver Health dba Arizona Liver Health | Chandler | Arizona |
United States | The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas |
United States | Southern Therapy and Advanced Research | Jackson | Missouri |
United States | Henry Ford Columbus Center | Novi | Michigan |
United States | University of California Davis Medical Center | Sacramento | California |
United States | American Research Corporation at the Texas Liver Institute | San Antonio | Texas |
United States | Pinnacle Clinical Research | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
CymaBay Therapeutics, Inc. |
United States, Korea, Republic of, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate maximum concentration (Cmax) of seladelpar and metabolites | 17 weeks | ||
Primary | Evaluate the time to reach Cmax (Tmax) of seladelpar and metabolites | 17 weeks | ||
Primary | Evaluate area under the concentration curve versus time curve of seladelpar and metabolites | 17 weeks | ||
Primary | Evaluate the amount of seladelpar excreted in the urine (Ae) | 17 weeks | ||
Primary | Evaluate safety and tolerability as assessed by the incidence of treatment emergent adverse events and serious treatment emergent adverse events across child pugh treatment groups | 17 weeks |
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