A Study of a New LY900014 Formulation in Healthy Participants

Study Overview
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Brief Summary
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This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Official Title
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Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation

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) Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study Are nonsmokers, 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 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30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

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 7.5 Units (U)<br>Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Insulin Lispro<br>Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods. | Drug: Insulin Lispro (Humalog)<br>* Administered SC<br>* Other names: Humalog;|
| Experimental: LY900014 15 U<br>Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 30 U<br>Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) |  | 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period. | 

Secondary Outcome Measures

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