A Study of Olomorasib (LY3537982) in Healthy Participants

A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Olomorasib (LY3537982) in Healthy Participants

The main purpose of this study in healthy participants is to determine the effect of fluconazole on the amount of study drug that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 7 weeks and will require 12 overnight stays in the research center.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Fluconazole; Drug: Olomorasib

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117-5116
      • Fortrea Clinical Research Unit - Daytona Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Must have a Body Mass Index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2)
• Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).

Exclusion Criteria:

• History or presence of the following conditions:

  • metabolic disease
  • biliary disease
  • gastrointestinal disease
  • hematological disease
  • neurological disease
  • significant history of hepatic disease
  • clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to Day 1
• Abnormal blood pressure or pulse rate
• Have a 12-lead electrocardiogram (ECG) abnormality, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG analysis
• History of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix, that have been resected with no evidence of metastatic disease for 3 years.
• Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies
• Have a positive hepatitis C antibody test
• Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA), or both.
• Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation
• Use of tobacco, smoking-cessation products, electronic (e)-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to first olomorasib administration and through the end of trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Olomorasib + Fluconazole; Administered orally	Drug: Fluconazole; Administered orally; Drug: Olomorasib; Administered orally; Other Names: LY3537982
Other: Olomorasib; Administered orally	Drug: Olomorasib; Administered orally; Other Names: LY3537982

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib	PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib	Baseline, Day 12
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib	PK: Cmax of Olomorasib	Baseline, Day 12

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or, Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Actual): April 17, 2026
• Study Completion (Actual): April 17, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Fluconazole
• Other Study ID Numbers: 27768; J3M-MC-JZQM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No