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A Study of LY900018 in Participants With a Common Cold

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02778100
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
Locemia Solutions ULC
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety of LY900018 in participants with a common cold, some of whom will also take a nasal decongestant. The study will investigate how the body processes LY900018 and the effect of LY900018 on the body. The study will last up to 30 days for each participant.

Condition or disease Intervention/treatment Phase
Common Cold Drug: LY900018 Drug: Oxymetazoline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : March 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
Experimental: LY900018 - Common Cold
Cohort 1 - LY900018 administered once, intranasally, in participants with a common cold.
Drug: LY900018
Administered intranasally.
Other Name: AMG 504-1

Experimental: LY900018 - Symptom-Free
Cohort 1 - LY900018 administered once, intranasally, in participants who have recovered from a common cold.
Drug: LY900018
Administered intranasally.
Other Name: AMG 504-1

Experimental: LY900018 - Common Cold+Oxymetazoline
Cohort 2 - LY900018 administered once, intranasally, in participants with a common cold who are taking oxymetazoline.
Drug: LY900018
Administered intranasally.
Other Name: AMG 504-1

Drug: Oxymetazoline
Administered intranasally.




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Study Completion (Day 30) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area Under the Curve from Time Zero to the Last Quantifiable Concentration (AUC[0-t]) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  2. Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  3. Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  4. Pharmacokinetics: Maximum Concentration (Cmax) of LY900018 [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  5. Pharmacodynamics: Area Under the Effect Concentration Time Curve (AUEC₀-₃) of Blood Glucose (BG) [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  6. Pharmacodynamics: Tmax of BG [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]
  7. Pharmacodynamics: Cmax of BG [ Time Frame: Period 1, Day 1 (Cohorts 1 and 2) and Period 2, Day 1 (Cohort 1, only) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778100


Locations
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Canada, Quebec
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, Canada, H3P 3P1
Sponsors and Collaborators
Eli Lilly and Company
Locemia Solutions ULC
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02778100     History of Changes
Other Study ID Numbers: 16425
GUO-P2-628 ( Other Identifier: AMG Medical Inc. )
AMG 104 ( Other Identifier: AMG Medical Inc. )
I8R-MC-IGBE ( Other Identifier: Eli Lilly and Company )
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Nasal Decongestants
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oxymetazoline
Phenylephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents