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A Study of LY3185643 and rGlucagon in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951780
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Drug: LY3185643 Drug: rGlucagon Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : January 24, 2017
Actual Study Completion Date : March 1, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3185643
LY3185643 administered subcutaneous (SC)
 Drug: LY3185643
Administered SC
Experimental: rGlucagon
rGlucagon administered subcutaneous (SC)
 Drug: rGlucagon
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon [ Time Frame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose ]
    Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.

  2. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon [ Time Frame: 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.

  3. Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon [ Time Frame: -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.

  4. Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon [ Time Frame: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose ]
    Cmax was assessed for C-peptide of LY3185643 and rGlucagon

  5. Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon [ Time Frame: -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.

  6. Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon [ Time Frame: -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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951780


Locations
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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, Singapore
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] December 8, 2016
Statistical Analysis Plan  [PDF] October 19, 2016

More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02951780    
Other Study ID Numbers: 16502
I8Z-MC-APCA ( Other Identifier: Eli Lilly and Company )
First Posted: November 1, 2016    Key Record Dates
Results First Posted: September 30, 2019
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.