Trial Summary
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
Status
Recruiting
Condition
Primary Biliary Cholangitis , Compensated Cirrhosis , Hepatic Impairment
Actual Start Date
September 17, 2021
Estimated Primary Completion Date
June 2024
About the Trial
This is an open-label trial examining the pharmacokinetics of a single dose or multiple doses (up to 28 days) of seladelpar in patients who have liver cirrhosis due to primary biliary cholangitis (PBC). The aim of this trial is to understand the safety of seladelpar and how it is absorbed and metabolized in patients with PBC and varying degrees of hepatic impairment due to cirrhosis (Child-Pugh A without portal hypertension, Child-Pugh A with portal hypertension, Child-Pugh B, and Child-Pugh C). This trial will enroll at least 24 patients, 6 with each level of hepatic impairment. Secondary outcomes of this trial will include changes in liver biochemistry in patients who are treated for up to 28 days.
Detailed Info
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)
ClinicalTrials.gov ID
NCT04950764
Study Phase
Phase 1
Estimated Enrollment
24
Estimated Primary Completion Date
June 2024
Study Type
Interventional
Interventions
- DRUG: Seladelpar 10 mg
- Seladelpar 10 mg single oral dose
- DRUG: Seladelpar 10 mg or less
- Seladelpar 10 mg or less, once daily for 28 days
Sponsor
CymaBay Therapeutics, Inc.
Eligibility
Inclusion Criteria
Qualities or factors you must have to be included in the trial. The trial site may advise you on additional factors.
Gender
All
Age
18 and 80 years of age (inclusive)
Child-Pugh score
CP-A, CP-A + PHT, CP-B or CP-C
- 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
Exclusion Criteria
Qualities or factors that would not allow you to participate in the trial. The trial site may advise you on additional factors.
- Subjects must not meet any of the following criteria to be 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
Locations
The following cities have Seladelpar clinical trial sites. Please check back often as locations will be updated.
Enrollment
For more information on enrollment into our current clinical trials, please contact us or visit clinicaltrials.gov for location information.
About Primary Biliary Cholangitis (PBC)?
PBC is a rare, chronic, autoimmune liver disease that progressively destroys the liver’s bile ducts.
Read More About PBCFrequently Asked Questions
What is a clinical trial?
A Clinical Trial is a type of research study that examines how well a potential therapy works in humans.
Why is this trial being done?
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
How do I know if I can participate in this trial?
This clinical trial has certain criteria that a person has to meet to determine if they can participate. After you have discussed the trial with your doctor, specific tests will be done to see if you qualify for this study.
Who is sponsoring this trial?
CymaBay Therapeutics, Inc. is sponsoring this clinical trial.
How many people will participate in this trial?
There will be a total of 192 patients enrolled in this clinical trial.
Where do I go to participate in this clinical trial?
After you have discussed the trial with your doctor, contact CymaBay Therapeutics, Inc. to coordinate with the study site closest to where you live.
The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.