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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04950764
Other study ID # CB8025-21838
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 17, 2021
Est. completion date June 2024

Study information

Verified date April 2023
Source CymaBay Therapeutics, Inc.
Contact Barry Crittenden, MD
Phone 510-293-8800
Email medinfo@cymabay.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Seladelpar 10 mg
Seladelpar 10 mg single oral dose
Seladelpar 10 mg or less
Seladelpar 10 mg or less, once daily for 28 days

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
CymaBay Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

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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