A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
NCT07124013
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Eli Lilly and Company
Start date
2025-09-16
Number of sites
- 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.
- Short title
- A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
- Official 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-01-05
- First posted
- 2025-08-15
- Registry last updated
- 2026-01-16
- Primary completion date
- 2026-01-05
- Start date
- 2025-09-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07124013
- ClinicalTrials.gov ID
- NCT07124013
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Crossover
- Purpose
- Basic science
- Masking
- No masking
Sources for study design
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
Timeframe: 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
Timeframe: Day 1 (Predose) through Day 7 (72 Hours Postdose)
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Sources for eligibility
- Souseikai Fukuoka Mirai HospitalFukuoka, Japan
Sources for sites
Other registry identifiers
- J3M-JE-JZQL
Sources for references