A Study of Nasal Glucagon in Participants With a Common Cold

NCT02778100 | Completed Phase 1 Results

• 4 other identifiers: 16425GUO-P2-628AMG 104I8R-MC-IGBE
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

Nasal Glucagon (NG) - Common Cold

EXPERIMENTAL

Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold.

Drug: Nasal Glucagon

Nasal Glucagon (NG) - Symptom-Free

EXPERIMENTAL

Cohort 1 - NG administered once in participants who have recovered from a common cold.

Drug: Nasal Glucagon

NG - Common Cold+Oxymetazoline

EXPERIMENTAL

Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline.

Drug: Nasal Glucagon; Drug: Oxymetazoline

Interventions

Nasal Glucagon DRUG

Administered intranasally.

Also known as: LY900018, AMG 504-1

NG - Common Cold+Oxymetazoline; Nasal Glucagon (NG) - Common Cold; Nasal Glucagon (NG) - Symptom-Free

Oxymetazoline DRUG

Administered intranasally.

NG - Common Cold+Oxymetazoline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Locemia Solutions ULC: collaborator

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Common Cold

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 19, 2016
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2016-05

Locations

CA (1)