Recruiting
Phase 1

Olomorasib

Sponsor:

Eli Lilly and Company

Code:

NCT07794592

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Olomorasib test

Olomorasib reference

Study Details

Brief summary:

The main purpose of this study is to compare how much and how quickly olomorasib gets into the bloodstream when it is taken in 2 different ways, and to check for any side effects. For each participant, the study will last about 6 weeks and will include 1 stay in the Clinical Research Unit (CRU) which consists of 7 nights.

Conditions

Healthy Volunteers

Study ID

NCT07794592

Start date

Aug 28, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Have a body mass index (BMI) within the range 18.0 to 30.0 kilograms per square meter (kg/m2)
  • Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP)
  • Able to comply with the 7-night stay at the study site.

Exclusion Criteria:

  • History or presence of any of the following conditions, such as metabolic disease, biliary disease, gastrointestinal disease, hematological disease, neurological disease, presence of hepatic disease, active cardiovascular disease or history of myocardial infarction or unstable angina within 6 months prior to the first dose of olomorasib
  • Have an abnormal blood pressure or pulse rate
  • Have known allergies to olomorasib or related compounds.
  • Have clinically significant history of multiple or severe drug hypersensitivity reactions or drug allergies as determined by the investigator, such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine.
  • History or presence of any illness or psychiatric condition that would interfere with the ability to provide informed consent or comply with study instructions,
  • Show evidence of Human immunodeficiency virus (HIV) infection or positive HIV antibodies at screening.
  • Have a positive hepatitis C antibody test unless a confirmatory HCV RNA test is negative.
  • 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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Olomorasib test

Olomorasib administered orally

experimental: Olomorasib reference

Olomorasib administered orally

Interventions

Olomorasib test

Administered orally

Olomorasib reference

Administered orally

Primary outcome measure

  • Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib [ Time Frame: Day 1 to Day 7 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.