Healthy
Conditions
Brief summary
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.
Interventions
DRUGOlomorasib
Administered orally
DRUGFluconazole
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib | Baseline, Day 12 | PK: Area Under the Concentration Versus Time Curve (AUC) of olomorasib |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib | Baseline, Day 12 | PK: Cmax of Olomorasib |
Countries
United States
Contacts
STUDY_DIRECTORContact Lilly at 1-877-CTLILLY (1-877-285-4559) or
Eli Lilly and Company
Outcome results
None listed