A Study of Lispro Formulations in Healthy Participants

Study Overview
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Brief Summary
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The purposes of this study are to determine: Part A How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation. The safety of insulin lispro in different formulations and any side effects that might be associated with it. Part B: How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A). The safety of insulin lispro in different formulations and any side effects that might be associated with it. Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.

Official Title
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Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Overtly healthy males or females (nonchildbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination Exclusion Criteria: - Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Lispro (A)<br>Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods. | Drug: Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: Part A: Lispro (B)<br>Formulation B: Single dose of lispro administered SC in one of five periods. | Drug: Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: Part A: Lispro (C)<br>Formulation C: Single dose of lispro administered SC in one of five periods. | Drug: Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: Part A: Lispro (D)<br>Formulation D: Single dose of lispro administered SC in one of five periods. | Drug: Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: Part A: Lispro (Reference)<br>Reference formulation: Single dose of lispro administered SC in one of five periods. | Drug: Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: Part B: Lispro<br>Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. | Drug: Lispro<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 |
| --- | --- | --- |
| Part A and B: Pharmacokinetics: Area Under The Concentration Curve (AUC) of LY275585 |  | Predose through day 1 in each period |