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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02778100

Enrollment

Registered

2016-05-19

Start date

2013-03-31

Completion date

2013-04-30

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold

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.

Interventions

DRUGNasal Glucagon

Administered intranasally.

DRUGOxymetazoline

Administered intranasally.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With One or More Serious Adverse Event(s) (SAEs)	Baseline up to Study Completion (Day 30)	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

Measure	Time frame
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
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
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
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

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Nasal Glucagon (NG) Dose of 3 mg NG administered once to participants with a common cold.	18
NG Plus Oxymetazoline Dose of 3 mg NG administered once to participants with a common cold, who are taking oxymetazoline.	18
Total	36

Withdrawals & dropouts

Period	Reason	FG000	FG001
Period 1 (Common Cold)	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Nasal Glucagon (NG)	NG Plus Oxymetazoline	Total
Age, Continuous	32 years	29 years	30.5 years
Race/Ethnicity, Customized Black	2 Participants	3 Participants	5 Participants
Race/Ethnicity, Customized Other	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White	16 Participants	14 Participants	30 Participants
Region of Enrollment Canada	18 Participants	18 Participants	36 Participants
Sex: Female, Male Female	9 Participants	10 Participants	19 Participants
Sex: Female, Male Male	9 Participants	8 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	18 / 18	17 / 17	18 / 18
serious Total, serious adverse events	0 / 18	0 / 17	0 / 18

Outcome results

Primary

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.

Time frame: Baseline up to Study Completion (Day 30)

Population: All enrolled participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
NG - Common Cold	Number of Participants With One or More Serious Adverse Event(s) (SAEs)	0 Participants
NG - Symptom-Free	Number of Participants With One or More Serious Adverse Event(s) (SAEs)	0 Participants
NG - Common Cold+Oxymetazoline	Number of Participants With One or More Serious Adverse Event(s) (SAEs)	0 Participants

Secondary