Multiple olomorasib (LY3537982) capsules in healthy adults

An Open-Label, Randomized, 3-Way Crossover Study Comparing the Pharmacokinetics of Multiple Olomorasib (LY3537982) Capsules

This trial tests how much olomorasib gets into the blood and how long the body takes to clear it in healthy adults who take the drug by mouth.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 2 sites (San Antonio, Texas and 1 other locations)
• Trial ID: NCT07044271 on ClinicalTrials.gov

What this trial studies

Healthy adult volunteers will receive multiple oral doses of olomorasib with frequent blood sampling to measure drug concentrations and elimination over time. The overall participation period is about seven weeks and includes 10 consecutive overnight stays at the research center for intensive monitoring. Eligible participants must be without clinically significant disease, have a BMI of 18.0–30.0 kg/m², and be assigned male or female at birth but not of childbearing potential. The study is sponsored by Eli Lilly and conducted at ICON Early Phase Services sites in San Antonio, TX and Salt Lake City, UT.

Who should consider this trial

Good fit: Healthy adults with BMI 18.0–30.0 kg/m² who are assigned male or female at birth and are not of childbearing potential, have no clinically significant disease or relevant allergies, can avoid recent medications, and can commit to the inpatient stays are ideal.

Not a fit: People seeking therapeutic benefit, those who are pregnant or lactating, of childbearing potential, have significant medical conditions, drug/food allergies, or recent medication use are unlikely to benefit from this healthy-volunteer pharmacokinetic study.

Why it matters

Potential benefit: If successful, the results will help define safe dosing schedules and timing for later patient studies and support further development of olomorasib.

How similar studies have performed: Pharmacokinetic studies in healthy volunteers are a routine, well-established step that has successfully informed dosing for many oral drugs, though olomorasib-specific clinical outcomes beyond early-phase data remain limited.

Eligibility criteria

Inclusion Criteria:

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive
* Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).

Exclusion Criteria:

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy
* Have used or plan to use medication within 14 days or 5 half-lives, whichever is longest, prior to admission, with the exception occasional acetaminophen at doses less than or equal to 2 g/day.

Where this trial is running

San Antonio, Texas and 1 other locations

• ICON Early Phase Services — San Antonio, Texas, United States (RECRUITING)
• ICON — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Conditions: Healthy