A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants
Sponsor: Eli Lilly and Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib
Time frame: Predose on Day 1 up to 96 hours postdose
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib
Time frame: Predose on Day 1 up to 96 hours postdose
Eligibility Criteria
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 the CRU and the follow-up phone call. * Healthy participants: In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee). * Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy. Exclusion Criteria: * Females who are lactating or of childbearing potential. * History or presence of any of the following, dee…
Read full criteria on CT.gov →✦ Analyst Commentary
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