A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

Launched by ELI LILLY AND COMPANY · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called olomorasib (LY3537982) to understand how it is processed in the body, especially in people with different levels of liver impairment (mild, moderate, or severe) compared to healthy individuals with normal liver function. The study aims to find out how well the medication enters the bloodstream and how long it takes for the body to get rid of it. Additionally, the researchers will assess the safety and tolerability of olomorasib during the trial, which will last up to 6 weeks for each participant.

To participate in this trial, individuals must be between 18 and 75 years old and either be in good health or have a documented liver impairment, such as cirrhosis. Participants will need to stay at a clinical research facility for 5 to 6 nights and attend follow-up phone calls after the study. Certain criteria, like having no significant medical conditions or being on certain medications, will determine eligibility. This study is currently recruiting participants, and everyone involved will be closely monitored to ensure their safety throughout the trial.

Gender

ALL

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, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
• • 1. Metabolic disease
• • 2. Gastrointestinal disease
• • 3. Hematological disease
• • 4. Neurological disease
• • 5. History or presence of clinically significant cardiovascular disease.
• • Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
• • Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
• • Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
• • Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor.
• • History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.