A Study of Nasal Glucagon in Participants With a Common Cold

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Common Cold

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nasal Glucagon (NG) - Common Cold

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

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered intranasally.

Nasal Glucagon (NG) - Symptom-Free

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

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered intranasally.

NG - Common Cold+Oxymetazoline

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

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered intranasally.

Oxymetazoline

Intervention Type DRUG

Administered intranasally.

Interventions

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Nasal Glucagon

Administered intranasally.

Intervention Type DRUG

Oxymetazoline

Administered intranasally.

Intervention Type DRUG

Other Intervention Names

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LY900018 AMG 504-1

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes