A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

An Open-Label, Phase 1 Study to Investigate the Comparability of the Pharmacokinetics of Olomorasib (LY3537982) Between Two Capsule Formulations and to Evaluate the Food Effect in Healthy Japanese Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07124013

Enrollment

191

Registered

2025-08-15

Start date

2025-09-16

Completion date

2026-01-05

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGOlomorasib

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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 * Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib * Show evidence of hepatitis B or positive hepatitis B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.

Design outcomes

Primary

Measure	Time frame
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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026