A Study of LY3185643 and rGlucagon in Healthy Participants

NCT02951780 | Completed Phase 1 Results

• 2 other identifiers: 16502I8Z-MC-APCA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

LY3185643

EXPERIMENTAL

LY3185643 administered subcutaneous (SC)

Drug: LY3185643

rGlucagon

EXPERIMENTAL

rGlucagon administered subcutaneous (SC)

Drug: rGlucagon

Interventions

LY3185643 DRUG

Administered SC

LY3185643

rGlucagon DRUG

Administered SC

rGlucagon

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 1, 2016
• Study Start: November 1, 2016
• Primary Completion: January 24, 2017
• Study Completion: March 1, 2017
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)