Back to resultsA Study of Nasal Glucagon in Participants With a Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Nasal Glucagon
Oxymetazoline
Sponsored by
About this trial
This is an interventional basic science trial for Common Cold
Eligibility Criteria
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.
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Nasal Glucagon (NG) - Common Cold
Nasal Glucagon (NG) - Symptom-Free
NG - Common Cold+Oxymetazoline
Arm Description
Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold.
Cohort 1 - NG administered once in participants who have recovered from a common cold.
Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) of Baseline-Adjusted Glucose
Full Information
NCT ID
NCT02778100
First Posted
May 18, 2016
Last Updated
August 14, 2019
Sponsor
Eli Lilly and Company
Collaborators
Locemia Solutions ULC
1. Study Identification
Unique Protocol Identification Number
NCT02778100
Brief Title
A Study of Nasal Glucagon in Participants With a Common Cold
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Locemia Solutions ULC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal Glucagon (NG) - Common Cold
Arm Type
Experimental
Arm Description
Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold.
Arm Title
Nasal Glucagon (NG) - Symptom-Free
Arm Type
Experimental
Arm Description
Cohort 1 - NG administered once in participants who have recovered from a common cold.
Arm Title
NG - Common Cold+Oxymetazoline
Arm Type
Experimental
Arm Description
Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline.
Intervention Type
Drug
Intervention Name(s)
Nasal Glucagon
Other Intervention Name(s)
LY900018, AMG 504-1
Intervention Description
Administered intranasally.
Intervention Type
Drug
Intervention Name(s)
Oxymetazoline
Intervention Description
Administered intranasally.
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs)
Description
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.
Time Frame
Baseline up to Study Completion (Day 30)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
Time Frame
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
Title
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
Time Frame
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
Title
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time Frame
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
Title
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time Frame
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
Title
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours
Time Frame
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
Title
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time Frame
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
Title
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) of Baseline-Adjusted Glucose
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Mount-Royal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada
12. IPD Sharing Statement
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A Study of Nasal Glucagon in Participants With a Common Cold
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