A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

Launched by ELI LILLY AND COMPANY · Aug 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called olomorasib to see how food affects the amount of the drug in the blood when taken in two different capsule forms. The study is focused on healthy Japanese men, and it will last about six weeks. The goal is to understand if taking olomorasib with or without food changes how the body absorbs the medicine.

To join the study, participants need to be healthy Japanese men between the ages of about 20 to 74 years old, with a body weight in a certain range (measured by body mass index between 18.5 and 30). Before joining, participants will have a medical check-up to ensure they are healthy and don’t have certain infections or allergies to the drug. During the study, participants will take olomorasib capsules and have blood tests to measure how much medicine is in their system. This study is not yet open for recruiting volunteers.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Japanese participants who are overtly healthy as determined by medical evaluation including medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations.
• • Have a body mass index within the range 18.5 to 30.0 kilograms per square meter (kg/m²), inclusive, at screening.
• • Participants assigned male at birth (AMAB) may participate in this study.
• Exclusion Criteria:
• • Have a 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.
• • Have known allergies to olomorasib or any component of the formulation, or related compounds.
• • Use of any other investigational drug or device within 30 days or 5 half-lives (if known), whichever is longer, of the first dose of study drug.
• • Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib
• • Show evidence of hepatitis B or positive hepatitis B surface antigen.
• • Show evidence of hepatitis C or have a positive hepatitis C virus antibody test.
• • Show evidence of HIV infection or positive HIV antigen or HIV antibodies.
• • Show evidence of syphilis or have a positive syphilis test.