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Completed

NCT Number: NCT02951780

A Study of LY3185643 and rGlucagon in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3185643

Drug

Administered SC

rGlucagon

Drug

Administered SC

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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