An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Conditions
- Hepatic ImpairmentPrimary Biliary CholangitisCompensated Cirrhosis
- Interventions
- Registration Number
- NCT04950764
- Lead Sponsor
- Gilead Sciences
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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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)
-
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.
-
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.
-
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.
-
Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C
-
Screening laboratory parameters:
- ALP, ALT and AST < 10 × ULN
- Total bilirubin ≤ 5 × ULN
-
Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1
-
At screening confirmed diagnosis of PBC
-
MELD-Na scores of 6 to 24
- Clinically significant or history of acute or chronic liver disease of an etiology other than PBC
- Patients with a diagnosis of overlapping PBC and autoimmune hepatitis
- History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
- Presumptive or diagnosed infection that requires systemic therapy within 12 weeks of Screening and through Day 1
- Female subjects who are pregnant or nursing
- Screening ECG that demonstrates a QT interval ≥ 500 msec, or any other significant ECG finding with clinically significant abnormalities as determined by the Investigator
- Positive for HBsAg, HCV RNA, or anti HIV antibody
- 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
- Has experienced an illness that is considered by the Investigator to be clinically significant within 2 weeks before administration of investigational product
- 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
- 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
- Use of an experimental or unapproved treatment for PBC within 30 days of Baseline
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Seladelpar 10 mg Seladelpar 10 mg Part A: Single oral dose 10 mg Seladelpar 10 mg or less Seladelpar 10 mg or less Part B: Multiple oral dose of 10 mg or less
- Primary Outcome Measures
Name Time Method Evaluate maximum concentration (Cmax) of seladelpar and metabolites 17 weeks Evaluate the time to reach Cmax (Tmax) of seladelpar and metabolites 17 weeks Evaluate area under the concentration curve versus time curve of seladelpar and metabolites 17 weeks Evaluate the amount of seladelpar excreted in the urine (Ae) 17 weeks 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (40)
Southern Therapy and Advanced Research LLC
🇺🇸Jackson, Mississippi, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research- SA
🇺🇸San Antonio, Texas, United States
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Hospital General Universitario Gregorio Maran
🇪🇸Madrid, Spain
NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham
🇬🇧Birmingham, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Arizona Liver Health
🇺🇸Chandler, Arizona, United States
University of California Davis
🇺🇸Sacramento, California, United States
University of Colorado Anschutz
🇺🇸Aurora, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Arizona Liver Health
🇺🇸Chandler, Arizona, United States
University of California Davis
🇺🇸Sacramento, California, United States
University of Colorado Anschutz
🇺🇸Aurora, Colorado, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Southern Therapy and Advanced Research LLC
🇺🇸Jackson, Mississippi, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research- SA
🇺🇸San Antonio, Texas, United States
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hospital General Universitario Gregorio Maran
🇪🇸Madrid, Spain
NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham
🇬🇧Birmingham, United Kingdom
The Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom