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OpenTrials
Completed

NCT Number: NCT07124013

A Study of Olomorasib (LY3537982) in Healthy Japanese Participants

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib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

Treatment and study plan

Olomorasib

Drug

Administered orally

Other names: LY3537982

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib

    Time frame: Day 1 (Predose) through Day 7 (72 Hours Postdose)

  2. PK: Area under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib

    Time frame: Day 1 (Predose) through Day 7 (72 Hours Postdose)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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