A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

NCT07124013 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27293J3M-JE-JZQL
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Olomorasib Test (Part A)

EXPERIMENTAL

Olomorasib test formulation administered orally with or without food.

Drug: Olomorasib

Olomorasib Reference (Part B)

EXPERIMENTAL

Olomorasib reference formulation administered orally with or without food.

Drug: Olomorasib

Olomorasib Test (Part B)

EXPERIMENTAL

Olomorasib test formulation administered orally with or without food.

Drug: Olomorasib

Interventions

Olomorasib DRUG

Administered orally

Also known as: LY3537982

Olomorasib Reference (Part B); Olomorasib Test (Part A); Olomorasib Test (Part B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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• Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 15, 2025
• Study Start: September 16, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)