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

Phase 1

Not yet recruiting

• Conditions: Hepatic Insufficiency; Healthy
• Interventions: Drug: Olomorasib

• Registration Number: NCT06719128
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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 ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olomorasib (Mild Hepatic Impairment)	Olomorasib	Olomorasib administered orally.
Olomorasib (Moderate Hepatic Impairment)	Olomorasib	Olomorasib administered orally.
Olomorasib (Severe Hepatic Impairment)	Olomorasib	Olomorasib administered orally.
Olomorasib (Normal Hepatic Function)	Olomorasib	Olomorasib administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib	Predose on Day 1 up to 96 hours postdose	PK: Cmax of Olomorasib
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib	Predose on Day 1 up to 96 hours postdose	PK: AUC0-inf of Olomorasib

Trial Locations

Locations (4)

Orange County Research Center; 🇺🇸 Lake Forest, California, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

American Research Corporation at Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States