Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 55

Two Ways of Taking Olomorasib in Healthy Volunteers

Official title: An Open-Label Randomized Study to Evaluate Olomorasib Administration as an Intact Oral Capsule and as a Water Dispersion to Healthy Participants.

Run by Eli Lilly and Company · NCT07794592 · Data updated 2026-11-12

This early-phase study tests two methods of taking olomorasib to see how much and how fast the medicine enters the blood, and to check for side effects in healthy adults.

More Healthy Adult Male and Female Volunteers trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment24 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations1 site (Daytona Beach, Florida)
StatusRecruiting
StartedAugust 28, 2026
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedSeptember 22, 2026
Trial IDNCT07794592 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy adults with BMI 18.0–30.0 kg/m2, AMAB or AFAB not of childbearing potential, and willing to complete a 7-night CRU stay.

Probably not a fit

Participants with active medical conditions, hepatic or cardiovascular disease, or allergy to olomorasib are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study compares two administration methods of olomorasib (the test and reference forms) in healthy volunteers. Participants will undergo a 6-week participation period, including a single 7-night stay at the Clinical Research Unit. The study collects pharmacokinetic data and safety information, with close monitoring of vital signs and laboratory tests. Eligible participants must be healthy, within specified BMI, and able to stay overnight at the site. The sponsor is Eli Lilly, and the study is conducted at Fortrea Clinical Research Unit in Daytona Beach, Florida.

Why it matters

Potential benefit: If successful, the study could clarify the best method of taking olomorasib and its safety profile in healthy adults.

How similar studies have gone: Previous early-phase studies in healthy volunteers have explored pharmacokinetics of similar compounds, but each drug requires its own evaluation; this design is standard for PK comparison.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fortrea Clinical Research Unit
    Daytona Beach, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.