Clinical trial NCT06719128: A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
Official title: An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatic Insufficiency
Healthy
Keywords: Olomorasib
Hepatic Impairment
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 to 6 weeks for each participant including the screening period.


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.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib
timeFrame: Predose on Day 1 up to 96 hours postdose
measure: PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib
timeFrame: Predose on Day 1 up to 96 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation at Texas Liver Institute
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: