Healthy Volunteers
Conditions
Brief summary
The main purpose of this study is to compare how much and how quickly olomorasib gets into the bloodstream when it is taken in 2 different ways, and to check for any side effects. For each participant, the study will last about 6 weeks and will include 1 stay in the Clinical Research Unit (CRU) which consists of 7 nights.
Interventions
DRUGOlomorasib test
Administered orally
DRUGOlomorasib reference
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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. * Have a body mass index (BMI) within the range 18.0 to 30.0 kilograms per square meter (kg/m2) * Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP) * Able to comply with the 7-night stay at the study site.
Exclusion criteria
* History or presence of any of the following conditions, such as metabolic disease, biliary disease, gastrointestinal disease, hematological disease, neurological disease, presence of hepatic disease, active cardiovascular disease or history of myocardial infarction or unstable angina within 6 months prior to the first dose of olomorasib * Have an abnormal blood pressure or pulse rate * Have known allergies to olomorasib or related compounds. * Have clinically significant history of multiple or severe drug hypersensitivity reactions or drug allergies as determined by the investigator, such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine. * History or presence of any illness or psychiatric condition that would interfere with the ability to provide informed consent or comply with study instructions, * Show evidence of Human immunodeficiency virus (HIV) infection or positive HIV antibodies at screening. * Have a positive hepatitis C antibody test unless a confirmatory HCV RNA test is negative. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib | Day 1 to Day 7 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed