Healthy
Conditions
Brief summary
The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants. The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein. Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug. This study has 3 parts: * Participants in Part A will complete 1 study period (approximately 1 week). * Participants in Part B will complete 3 study periods (approximately 3 weeks). * Participants in Part C will complete 2 study periods (approximately 2 weeks).
Detailed description
Parts B and C added per protocol amendment, approved in April 2019.
Interventions
DRUGLY3374849 - SC
Administered SC
DRUGInsulin Degludec - SC
Administered SC
DRUGLY3374849 - IV
Administered IV
DRUGInsulin Degludec - IV
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind in Part A. Open label in Parts B and C.
Intervention model description
Parts B and C are crossover design.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or a female who cannot become pregnant * Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²) * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study * Have veins suitable for easy blood collection and glucose solution infusion
Exclusion criteria
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months * Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female) * Smoke more than 10 cigarettes per day * Are infected with hepatitis B or human immunodeficiency virus (HIV) * Have a history of allergies or reactions to more than one drug, or significant severe drug allergy * Are taking illegal drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to study completion (estimated at 11 weeks) | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucodynamics: Total Amount of Glucose Infused (Gtot) | Baseline up to 36 hours post-dose for each study arm | Glucodynamics: Gtot |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849 | Baseline at predose through 6 days post-dose for each study arm | Pharmacokinetics: AUC of LY3374849 |
Countries
Singapore
Outcome results
None listed