A Study of LY3185643 and rGlucagon in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: rGlucagon; Drug: LY3185643

• Registration Number: NCT02951780
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study Start: 2016-11-01
• Study First Posted: 2016-11-01
• Primary Completion: 2017-01-24
• Study Completion: 2017-03-01
• Results First Submitted: 2019-06-28
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Results First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
rGlucagon	rGlucagon	rGlucagon administered subcutaneous (SC)
LY3185643	LY3185643	LY3185643 administered subcutaneous (SC)

Primary Outcome Measures

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

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇸🇬 Singapore, Singapore