A Study of Nasal Glucagon in Participants With a Common Cold

A Phase 1 Study to Evaluate the Effects of Common Cold and of Concomitant Administration of Nasal Decongestant on the Pharmacokinetics and Pharmacodynamics of a Novel Glucagon Formulation in Otherwise Healthy Subjects

The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in participants with a common cold, some of whom will also take a nasal decongestant. The study will investigate how the body processes NG and the effect of NG on the body. The study will last up to 30 days for each participant.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Drug: Nasal Glucagon; Drug: Oxymetazoline

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Mount-Royal, Quebec, Canada, H3P 3P1
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female participant presenting a score of 2 or 3 on nasal congestion and/or nasal discharge associated with at least one other symptom of common cold, as determined by the 8-item Jackson cold scale at screening and prior to dosing of period 1.
• Participant with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kilogram per square meter (kg/m²).
• Light-, non- or ex-smokers.
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, electrocardiogram [ECG] and urinalysis).

Exclusion Criteria:

• Presence of any nose piercings.
• History of significant hypersensitivity to glucagon, oxymetazoline or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
• Presence of severe fever (more than 39.5 degrees Celsius) at screening or prior to dosing of period 1.
• Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors.
• Presence or history of Type 1 or Type 2 diabetes.
• Presence or history of significant hypoglycemia or hyperglycemia.
• Use of beta-blockers, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before day 1 of the study.
• Fasting blood glucose above 6.1 mmol/L at screening, following a 12-hour fasting period.
• Fasting blood glucose assessed with a glucose meter above 6.1 mmol/L approximately 0.5 hour before each dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal Glucagon (NG) - Common Cold; Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold.	Drug: Nasal Glucagon; Administered intranasally.; Other Names: LY900018; AMG 504-1
Experimental: Nasal Glucagon (NG) - Symptom-Free; Cohort 1 - NG administered once in participants who have recovered from a common cold.	Drug: Nasal Glucagon; Administered intranasally.; Other Names: LY900018; AMG 504-1
Experimental: NG - Common Cold+Oxymetazoline; Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline.	Drug: Nasal Glucagon; Administered intranasally.; Other Names: LY900018; AMG 504-1; Drug: Oxymetazoline; Administered intranasally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Serious Adverse Event(s) (SAEs)	Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation participant administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Baseline up to Study Completion (Day 30)

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) of Baseline-Adjusted Glucose	Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Locemia Solutions ULC

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Glucagon; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 16425; GUO-P2-628 (Other Identifier: AMG Medical Inc.); AMG 104 (Other Identifier: AMG Medical Inc.); I8R-MC-IGBE (Other Identifier: Eli Lilly and Company)