COMPLETED

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

Conditions

Hepatic Insufficiency Healthy Olomorasib Hepatic Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of olomorasib will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.

Official Title

An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants

Quick Facts

Study Start:2024-12-06

Study Completion:2025-08-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06719128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Orange County Research Center

Lake Forest, California, 92630

United States

Clinical Pharmacology of Miami

Miami, Florida, 33014

United States

Orlando Clinical Research Center

Orlando, Florida, 32809

United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-06

Study Completion Date2025-08-25

Study Record Updates

Study Start Date2024-12-06

Study Completion Date2025-08-25

Terms related to this study

Keywords Provided by Researchers

Olomorasib
Hepatic Impairment

Additional Relevant MeSH Terms

Hepatic Insufficiency
Healthy