A Study of Olomorasib (LY3537982) in Healthy Participants

NCT07439250 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27768J3M-MC-JZQM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Olomorasib + Fluconazole

OTHER

Administered orally

Drug: Olomorasib; Drug: Fluconazole

Olomorasib

OTHER

Administered orally

Drug: Olomorasib

Interventions

Olomorasib DRUG

Administered orally

Also known as: LY3537982

Olomorasib; Olomorasib + Fluconazole

Fluconazole DRUG

Administered orally

Olomorasib + Fluconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Location

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)