Healthy Participants
Conditions
Brief summary
The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month.
Interventions
DRUGLY4064809 Test Formulation
Administered orally
DRUGLY4064809 Reference Formulation
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 healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission. * Have clinical laboratory test results within the normal range * Have normal blood pressure and pulse rate or not clinically significant * Have a BMI within the range 18 to 32 kg/m2 * Participants assigned male at birth or assigned female at birth who are not of childbearing potential
Exclusion criteria
* History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee): * metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome * bile duct disease, including removal of the gall bladder * digestive system disease * blood disease * disease of the nervous system * significant history of, or presence of, liver disease, including any abnormal liver function tests * heart disease * Have an abnormal electrocardiogram (ECG) at screening or admission * History of a major surgical procedure within 30 days prior to screening * Diagnosed or treated cancer within 5 years prior to screening, with the exception of the following cancers cured through treatment: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ carcinoma of the cervix cured through surgery * Clinically significant history of multiple or severe drug hypersensitivity reactions or drug allergies, as determined by the investigator * Have used or plan to use medication within 14 days prior to admission, or plan to use during the study with the exception of acetaminophen * Have creatinine lab clearance less than 90mL/min calculated using the Cockroft-Gault equation at screening * Have a positive Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody or human immunodeficiency virus 1 and 2 antibody results at the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809 | Predose on Day 1 Through Day 28 | PK: Cmax of LY4064809 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809 | Predose on Day 1 Through Day 28 | PK: AUC of LY4064809 |
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