Healthy
Conditions
Brief summary
The main purpose of this study is to measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center.
Interventions
DRUGOlomorasib
Single dose
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
3-way crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib | From Day 1, Predose up to 72 hours Postdose | PK: AUC(0-tlast) of Olomorasib |
| PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib | From Day 1, Predose up to 72 hours Postdose | PK: AUC(0-∞) of Olomorasib |
| PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib | From Day 1, Predose up to 72 hours Postdose | PK: Cmax of Olomorasib |
Countries
United States
Contacts
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