Mercy Medical Center | GI Research
Status and phase
Conditions
Treatments
About
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)
Enrollment
Sex
Ages
Volunteers
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 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:
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
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Loading...
Central trial contact
Barry Crittenden, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal