A Study of LY3185643 and rGlucagon in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3185643; Drug: rGlucagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT02951780

16502

I8Z-MC-APCA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

LY3185643

Experimental group

Description:

LY3185643 administered subcutaneous (SC)

Treatment:

Drug: LY3185643

rGlucagon

Experimental group

Description:

rGlucagon administered subcutaneous (SC)

Treatment:

Drug: rGlucagon