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NCT Number: NCT02778100

A Study of Nasal Glucagon in Participants With a Common Cold

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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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal Glucagon

Drug

Administered intranasally.

Other names: LY900018, AMG 504-1

Oxymetazoline

Drug

Administered intranasally.

Primary outcomes

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

    Time frame: 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Locemia Solutions ULC

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 19, 2016
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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