A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Olomorasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07124013

J3M-JE-JZQL (Other Identifier)

27293

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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191 participants in 3 patient groups

Olomorasib Test (Part A)

Experimental group

Description:

Olomorasib test formulation administered orally with or without food.

Treatment:

Drug: Olomorasib

Olomorasib Reference (Part B)

Experimental group

Description:

Olomorasib reference formulation administered orally with or without food.

Treatment:

Drug: Olomorasib

Olomorasib Test (Part B)

Experimental group

Description:

Olomorasib test formulation administered orally with or without food.

Treatment:

Drug: Olomorasib