A Study of Various Formulations of LY900014 in Healthy Participants

Study Overview
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Brief Summary
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This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

Official Title
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Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Multiple LY900014 Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY900014
* Drug: Insulin lispro (Humalog)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion) Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study Have veins suitable for easy blood collection and glucose solution infusion Exclusion Criteria: Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug Show signs of having an infection or infectious disease at the time of study entry

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY900014 Test B<br>Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods | Drug: LY900014<br>* Administered subcutaneously (SC)<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 Test A<br>Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods | Drug: LY900014<br>* Administered subcutaneously (SC)<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 Test C<br>Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods | Drug: LY900014<br>* Administered subcutaneously (SC)<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 Test D<br>Formulation D: Single dose of LY900014 formulation administered SC in one of five periods | Drug: LY900014<br>* Administered subcutaneously (SC)<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Insulin Lispro<br>Reference formulation: Single dose of lispro administered SC in one of five periods | Drug: Insulin lispro (Humalog)<br>* Administered SC<br>* Other names: LY275585;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro |  | Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp |  | Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes. |