A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Olomorasib

• Registration Number: NCT07124013
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to compare and see how food affects the amount of olomorasib in the blood when olomorasib is taken in two different capsule forms. Participation in the study will last approximately 6 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Study First Posted: 2025-08-15
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-09
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 188

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• Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olomorasib Test (Part A)	Olomorasib	Olomorasib test formulation administered orally with or without food.
Olomorasib Reference (Part B)	Olomorasib	Olomorasib reference formulation administered orally with or without food.
Olomorasib Test (Part B)	Olomorasib	Olomorasib test formulation administered orally with or without food.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib	Day 1 (Predose) through Day 7 (72 Hours Postdose)
PK: Area under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib	Day 1 (Predose) through Day 7 (72 Hours Postdose)

Trial Locations

Locations (1)

Souseikai Fukuoka Mirai Hospital; 🇯🇵 Fukuoka, Japan