A Study of LY3185643 and rGlucagon in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951780
• Other study ID #: 16502
• Secondary ID: I8Z-MC-APCA
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 1, 2017
• Est. primary completion date: January 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3185643
Administered SC
• rGlucagon
Administered SC

Locations

Country	Name	City	State
Singapore	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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