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Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Seladelpar 10 mg
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Seladelpar 10 mg 		Part A: Single oral dose 10 mg
  • Drug: Seladelpar 10 mg
    Seladelpar 10 mg single oral dose
    Other names:
    • Livdelzi®
  • Drug: Seladelpar 10 mg or less
    Seladelpar 10 mg or less, once daily for 28 days
    Other names:
    • Livdelzi®
Experimental
Seladelpar 10 mg or less 		Part B: Multiple oral dose of 10 mg or less
  • Drug: Seladelpar 10 mg or less
    Seladelpar 10 mg or less, once daily for 28 days
    Other names:
    • Livdelzi®

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.