Seladelpar for Liver Disease

Recruiting at 30 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must be taking: Ursodeoxycholic acid

Must not be taking: Obeticholic acid, Fibrates

Disqualifiers: Other liver disease, Hepatobiliary malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Primary Biliary Cholangitis (PBC) and liver cirrhosis, classified as CP-A to CP-C. Participants must have been on Ursodeoxycholic acid for at least 12 weeks, not be pregnant or nursing, and agree to use contraception. Exclusions include other liver diseases, recent infections requiring systemic therapy, significant ECG abnormalities, substance abuse within the last six months, and certain medication use.

Inclusion Criteria

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

I have PBC with cirrhosis and my liver function is classified as CP-A, CP-A + PHT, CP-B, or CP-C.

I am willing to use birth control during and for 30 days after the study if I can have children and am sexually active.

Exclusion Criteria

I have liver disease not caused by primary biliary cholangitis.

I am not pregnant or nursing.

I need treatment for an infection before starting the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single oral dose of 10 mg Seladelpar

1 day

Treatment Part B

Participants receive multiple oral doses of 10 mg or less Seladelpar

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Seladelpar

Trial Overview The study tests how different levels of liver impairment affect the body's handling of Seladelpar in PBC patients. It involves oral dosing with either a fixed dose of Seladelpar (10 mg) or a potentially lower amount based on individual tolerance.

How Is the Trial Designed?

Group I: Seladelpar 10 mg or less Experimental Treatment 1 Intervention

Part B: Multiple oral dose of 10 mg or less

Group II: Seladelpar 10 mg Experimental Treatment 1 Intervention

Part A: Single oral dose 10 mg

Seladelpar is already approved in United States, European Union for the following indications:

Approved in United States as Livdelzi for:

• Primary biliary cholangitis

Approved in European Union as Livdelzi for:

• Primary biliary cholangitis

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

CymaBay Therapeutics, Inc.

Lead Sponsor

Trials

23

Recruited

3,200+