Healthy
Conditions
Brief summary
The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated. Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.
Interventions
DRUGLY3819469
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants who are overtly healthy as determined by medical evaluation * Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening * Are male or women not of childbearing potential
Exclusion criteria
* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data * Have any abnormality in the 12-lead electrocardiogram (ECG) * Are heavy alcohol drinkers or heavy cigarette smokers * Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission * Have lost or donated blood of more than 450 mililitres (mL) within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469 | Predose on day 1 up to postdose on day 85 | PK: AUC\[0-tlast\] of LY3819469 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469 | Predose on day 1 up to postdose on day 85 | PK: AUC\[0-∞\] of LY3819469 |
| PK: Maximum Observed Concentration (Cmax) of LY3819469 | Predose on day 1 up to postdose on day 85 | PK: Cmax of LY3819469 |
Countries
Singapore
Outcome results
None listed