How fluconazole changes olomorasib levels in healthy adults
A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Olomorasib (LY3537982) in Healthy Participants
This test sees if taking fluconazole changes how much olomorasib gets into the blood and how long it stays there in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (Daytona Beach, Florida) |
| Trial ID | NCT07439250 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study enrolls healthy adults to measure how fluconazole affects the pharmacokinetics of olomorasib. Participants will stay in the research unit for scheduled inpatient periods over about seven weeks, with 12 overnight stays and repeated blood sampling to measure drug levels and clearance. The protocol administers olomorasib alone and then with fluconazole while monitoring safety with laboratory tests, ECGs, and vital signs. Eligibility requires a BMI of 18.0–30.0 kg/m2 and excludes individuals with significant liver, cardiac, gastrointestinal, hematologic, neurologic, or metabolic disease.
Who should consider this trial
Good fit: Ideal participants are healthy adults with BMI 18.0–30.0 kg/m2 who are assigned male at birth or assigned female at birth but not of childbearing potential, and who can commit to inpatient visits and overnight stays.
Not a fit: People with active or significant liver, heart, gastrointestinal, hematologic, neurologic, or metabolic disease, abnormal vital signs or ECG abnormalities, or those who are of childbearing potential are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, results could help clinicians adjust olomorasib dosing or avoid harmful combinations when patients also take fluconazole.
How similar studies have performed: Similar drug–drug interaction pharmacokinetic studies are common and have routinely guided safe dosing for other oncology agents, although olomorasib-specific data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Must have a Body Mass Index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2) * Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP). Exclusion Criteria: * History or presence of the following conditions: * metabolic disease * biliary disease * gastrointestinal disease * hematological disease * neurological disease * significant history of hepatic disease * clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to Day 1 * Abnormal blood pressure or pulse rate * Have a 12-lead electrocardiogram (ECG) abnormality, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG analysis * 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. * Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies * Have a positive hepatitis C antibody test * Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA), or both. * Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation * Use of tobacco, smoking-cessation products, electronic (e)-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to first olomorasib administration and through the end of trial
Where this trial is running
Daytona Beach, Florida
- Fortrea Clinical Research Unit - Daytona Beach — Daytona Beach, Florida, United States (Recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.