A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-16

Study Completion Date

2026-01-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

NCT05350800

Healthy Volunteer

COMPLETED PHASE1

A Pharmacokinetic Study of TP-05 in Healthy Subjects

NCT05138796

Healthy

COMPLETED PHASE1

A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants

NCT06692348

Healthy

COMPLETED PHASE1

A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

NCT01379586

Healthy Adult Subjects

TERMINATED PHASE1

Study to Evaluate the Food Effect of TP-05 in Healthy Participants

NCT05720364

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Olomorasib Test (Part A)

Olomorasib test formulation administered orally with or without food.

Group Type EXPERIMENTAL

Olomorasib

Intervention Type DRUG

Administered orally

Olomorasib Reference (Part B)

Olomorasib reference formulation administered orally with or without food.

Group Type EXPERIMENTAL

Olomorasib

Intervention Type DRUG

Administered orally

Olomorasib Test (Part B)

Olomorasib test formulation administered orally with or without food.

Group Type EXPERIMENTAL

Olomorasib

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olomorasib

Administered orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3537982

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes