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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-MC-JZQM | Other Identifier | Eli Lilly and Company |
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The main purpose of this study in healthy participants is to determine the effect of fluconazole on the amount of study drug that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 7 weeks and will require 12 overnight stays in the research center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olomorasib + Fluconazole | Other | Administered orally |
|
| Olomorasib | Other | Administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olomorasib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib | PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib | Baseline, Day 12 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib | PK: Cmax of Olomorasib | Baseline, Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of the following conditions:
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
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| Name | Affiliation | Role |
|---|---|---|
| Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit - Daytona Beach | Daytona Beach | Florida | 32117-5116 | United States |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole | Drug | Administered orally |
|