CompletedPhase 1

An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

United States24 participantsStarted 2021-11-16

Plain-language summary

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 participant 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:
✓. Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1
✓. At screening confirmed diagnosis of PBC

Exclusion criteria

✕. 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

What they're measuring

Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)

Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)

Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)

Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)

Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)

Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose

Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)

Timeframe: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose

Trial details

NCT IDNCT04950764

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-24

Results submitted2026-02-27

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 participant 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:
✓. Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1
✓. At screening confirmed diagnosis of PBC

Exclusion criteria

✕. 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