HealthyPhase 1NCT07124013
A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
A Phase 1 study testing Olomorasib in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olomorasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteJapan
- Study dates
- 16 Sep 2025to 5 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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- Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Olomorasib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlomorasibDrug
Also called LY3537982
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Olomorasib Test (Part A) | Experimental | Olomorasib test formulation administered orally with or without food. Receives: Drug: Olomorasib |
| Olomorasib Reference (Part B) | Experimental | Olomorasib reference formulation administered orally with or without food. Receives: Drug: Olomorasib |
| Olomorasib Test (Part B) | Experimental | Olomorasib test formulation administered orally with or without food. Receives: Drug: Olomorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
Measured: 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
Measured: Day 1 (Predose) through Day 7 (72 Hours Postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start16 Sep 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124013
- Sponsor's protocol ID
- 27293
- Other IDs
- J3M-JE-JZQL
- Status last verified
- Jan 2026
- First submitted
- 13 Aug 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07124013
- Acronym / sponsor ID
- 27293
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olomorasib Test (Part A) | Experimental | Drug: OlomorasibOlomorasib test formulation administered orally with or without food. |
| Olomorasib Reference (Part B) | Experimental | Drug: OlomorasibOlomorasib reference formulation administered orally with or without food. |
| Olomorasib Test (Part B) | Experimental | Drug: OlomorasibOlomorasib test formulation administered orally with or without food. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlomorasibAlso: LY3537982Administered orally | Drug | Olomorasib Reference (Part B), Olomorasib Test (Part A), Olomorasib Test (Part B) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
Time frame: 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
Time frame: Day 1 (Predose) through Day 7 (72 Hours Postdose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olomorasib in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib (time frame: Day 1 (Predose) through Day 7 (72 Hours Postdose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.