A Study of LY3185643 and rGlucagon in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated. This study will last at least 35 days, not including screening.

Official Title
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A Randomized, 9-Way, Single-Dose, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of LY3185643 and rGlucagon in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3185643
* Drug: rGlucagon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy as determined by medical history and physical examination Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²) Exclusion Criteria: Have participated, within the last 30 days, in a clinical trial involving an investigational product Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG Abnormal blood pressure History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position History of vasovagal response such as fainting History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data History of/current insulinoma and/or pheochromocytoma Have used systemic glucocorticoids within 3 months before entry into the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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: LY3185643<br>LY3185643 administered subcutaneous (SC) | Drug: LY3185643<br>* Administered SC<br>|
| Experimental: rGlucagon<br>rGlucagon administered subcutaneous (SC) | Drug: rGlucagon<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon | Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon. | 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose | 
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon | Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon. | 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose | 
| Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon | Cmax was assessed for LY3185643 and rGlucagon. | -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose | 
| Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon | Cmax was assessed for C-peptide of LY3185643 and rGlucagon | -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose | 
| Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon | Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon. | -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose | 
| Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon | Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon. | -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose |