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OpenTrials
Completed

NCT Number: NCT07439250

A Study 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olomorasib

Drug

Administered orally

Other names: LY3537982

Fluconazole

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib

    Time frame: Baseline, Day 12

    PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib

  2. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib

    Time frame: Baseline, Day 12

    PK: Cmax of Olomorasib

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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