Healthy
Conditions
Brief summary
The main purpose of this study is to compare 3 different forms of LY4065967 - a tablet and 2 types of capsule - to see how much and how quickly each gets into the bloodstream after it is swallowed, and to check for any side effects. For each participant, the study will last about 7 weeks and will include 3 stays in the Clinical Research Unit (CRU). Each stay will last 3 nights.
Interventions
DRUGLY4065967 Tablet
Administered orally
DRUGLY4065967 Formulated Capsule
Administered orally
DRUGLY4065967 Capsule
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, and laboratory tests. * Have clinical laboratory test results within normal reference range for the population or investigative site. * Have an electrocardiogram (ECG) at screening considered to be within acceptable limits by the investigator. * Have a body mass index within the range 18.0 to 35.0 kilograms per square meter (kg/m²) (inclusive). * Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) may participate in this trial. * Have venous access sufficient to allow for blood sampling.
Exclusion criteria
* Have a history of or current clinically significant medical conditions, including cardiovascular disease, electrolyte abnormalities, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders that, in the judgment of the investigator, could predispose to arrhythmia, pose a risk with study participation, significantly alter the absorption, metabolism, or elimination of the study drug, or interfere with the interpretation of study data. * Have systolic blood pressure of 140 millimeters of mercury (mmHg) or greater and diastolic blood pressure of 90 mmHg or greater at screening. * Have a history of clinically significant known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy. * Have a history of alcohol, opioids, stimulants or hallucinogens use disorder within 2 years prior to screening or a current use disorder by Diagnostic and Statistical Manual of Mental Disorders (APA 2013).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)] | Baseline Up to Day 17 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 | Baseline Up to Day 17 |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t [AUC(0- tlast)] | Baseline Up to Day 17 |
Secondary
| Measure | Time frame |
|---|---|
| PK: Time of Maximum Observed Drug Concentration (tmax) | Baseline Up to Day 17 |
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