Phase
Condition
Liver Failure
Liver Disease
Primary Biliary Cholangitis
Treatment
Olomorasib
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females of non-childbearing potential.
Men or women with a body mass index of 18.0 to 40.0 kilograms per meter squared (kg/m²).
Able to comply with all study procedures, including the 5- to 6-night stays at theCRU and the follow-up phone call.
Healthy participants: In good health, determined by no clinically significantfindings from medical history, physical examination, 12-lead ECG, vital signmeasurements, or clinical laboratory evaluations at screening and/or admission asassessed by the investigator (or designee).
Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymalliver disease, which is confirmed and documented by at least one of the following:medical history, physical examination, hepatic ultrasound, computed axial tomographyscan, magnetic resonance imaging, and/or liver biopsy.
Exclusion
Exclusion Criteria:
Females who are lactating or of childbearing potential.
History or presence of any of the following, deemed clinically significant by theInvestigator (or designee), and/or Sponsor:
Metabolic disease
Gastrointestinal disease
Hematological disease
Neurological disease
History or presence of clinically significant cardiovascular disease.
Abnormal laboratory values determined to be clinically significant by theInvestigator (or designee).
Clinically significant abnormality, as determined by the Investigator (or designee),from physical examination.
Participation in any other investigational study drug trial involving administrationof any investigational drug in the past 30 days or 5 half-lives, whichever waslonger, prior to the first dose administration (Day 1).
Use or intention to use any prescription or over-the-counter medications within 14days prior to the first dose administration (Day 1) and through end of trial, unlessdeemed acceptable by the investigator (or designee) and medical monitor.
History or presence, upon clinical evaluation, of any illness that, in the opinionof the Investigator, would interfere with the ability to provide informed consent orcomply with study instructions, or that might confound the interpretation of thestudy results, or put the participant at undue risk.
Study Design
Connect with a study center
Orange County Research Center
Lake Forest, California 92630
United StatesActive - Recruiting
Clinical Pharmacology of Miami
Miami, Florida 33014
United StatesActive - Recruiting
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesActive - Recruiting
American Research Corporation at Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
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