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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Nasal Glucagon in Participants With a Common Cold

NCTNCT02778100 (opens ClinicalTrials.gov in a new tab)Other id16425Other idGUO-P2-628Other idAMG 104Other idI8R-MC-IGBE
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
36 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Canada

Start
Mar 2013
Primary completion
Apr 2013
Completion
Apr 2013
First posted
19 May 2016 (estimated)
Last update posted
18 Sept 2019
Conditions
Common Cold

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014
  1. Ph 1

    A Study of Nasal Glucagon in Participants With a Common Cold

    NCT02778100

    Mar 2013 to Apr 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Nasal GlucagonDrug
  • OxymetazolineDrug

Arms3

  • Experimental

    Nasal Glucagon (NG) - Common Cold

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

  • Experimental

    Nasal Glucagon (NG) - Symptom-Free

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

  • Experimental

    NG - Common Cold+Oxymetazoline

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs)

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

    Registry 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.

Secondary outcomes(7)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline up to Study Completion (Day 30)

Number of Participants With One or More Serious Adverse Event(s) (SAEs)

GroupValue (Participants)
NG - Common Cold0
NG - Symptom-Free0
NG - Common Cold+Oxymetazoline0
Secondary and other outcome results(7)
Secondary outcomeMean· 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

GroupValue (picogram*hour per millilitre (pg*hr/mL))Spread
NG - Common Cold1039.71020.81
NG - Symptom-Free631.8399.66
NG - Common Cold+Oxymetazoline868.4622.39
Secondary outcomeMean· 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

GroupValue (pg*hr/mL)Spread
NG - Common Cold1108.91055
NG - Symptom-Free669.3431.7
NG - Common Cold+Oxymetazoline1064.3838.4
Secondary outcomeMedian· 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

GroupValue (Hour (hr))
NG - Common Cold0.3
NG - Symptom-Free0.3
NG - Common Cold+Oxymetazoline0.3
Secondary outcomeMean· 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

GroupValue (picograms per millilitre (pg/mL))Spread
NG - Common Cold1145.4994.43
NG - Symptom-Free745.6548.42
NG - Common Cold+Oxymetazoline811.5597.51
Secondary outcomeMean· 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

GroupValue (Hour*millimoles per liter(hr*mmol/L))Spread
NG - Common Cold4.32.11
NG - Symptom-Free3.81.92
NG - Common Cold+Oxymetazoline4.22.06
Secondary outcomeMedian· 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

GroupValue (Millimoles per liter (mmol/L))
NG - Common Cold0.5
NG - Symptom-Free0.6
NG - Common Cold+Oxymetazoline0.7
Secondary outcomeMean· 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

GroupValue (Millimoles per liter (mmol/L))Spread
NG - Common Cold2.91.57
NG - Symptom-Free2.71.38
NG - Common Cold+Oxymetazoline3.41.42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
NG- Common ColdDose of 3 mg nasal glucagon (NG) administered once in participants with a common cold.–0 / 1818 / 18
NG - Symptom-FreeDose of 3 mg nasal glucagon (NG) administered once in participants who have recovered from a common cold.–0 / 1717 / 17
NG - Common Cold+OxymetazolineDose of 3 mg nasal glucagon (NG) administered once in participants with a common cold who are taking oxymetazoline.–0 / 1818 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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