Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GUO-P2-628 | Other Identifier | AMG Medical Inc. | |
| AMG 104 | Other Identifier | AMG Medical Inc. | |
| I8R-MC-IGBE | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Locemia Solutions ULC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Glucagon (NG) - Common Cold | Experimental | Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold. |
|
| Nasal Glucagon (NG) - Symptom-Free | Experimental | Cohort 1 - NG administered once in participants who have recovered from a common cold. |
|
| NG - Common Cold+Oxymetazoline | Experimental | Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug | Administered intranasally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Study Completion (Day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Glucagon (NG) 3 mg (Milligram) | Period 1: NG administered once in participants with a common cold. Period 2: NG administered once in participants who have recovered from a common cold. |
| FG001 | NG 3 mg Plus Oxymetazoline | Period 1 only: NG administered once to participants with a common cold, who are taking oxymetazoline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Common Cold) |
|
| ||||||||||||||||||
| Period 2 (No Cold Symptoms) |
|
All participants enrolled in Period 1.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Glucagon (NG) | Dose of 3 mg NG administered once to participants with a common cold. |
| BG001 | NG Plus Oxymetazoline | Dose of 3 mg NG administered once to participants with a common cold, who are taking oxymetazoline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled participants. | Posted | Count of Participants | Participants | Baseline up to Study Completion (Day 30) |
|
First dose of study drug (Day 1) until post-study completion (Day 30).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NG- Common Cold | Dose of 3 mg nasal glucagon (NG) administered once in participants with a common cold. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Oxymetazoline | Drug | Administered intranasally. |
|
| 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 |
| 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 |
| 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 |
| Canada |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| NG - Symptom-Free |
Dose of 3 mg NG administered once in participants who have recovered from a common cold. |
| OG002 | NG - Common Cold+Oxymetazoline | Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon | All enrolled participants with evaluable PK data. | Posted | Mean | Standard Deviation | picogram*hour per millilitre (pg*hr/mL) | 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 |
|
|
|
| Secondary | PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon | All enrolled participants with evaluable PK data. | Posted | Mean | Standard Deviation | pg*hr/mL | 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 |
|
|
|
| Secondary | PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | All enrolled participants with evaluable PK data. | Posted | Median | Full Range | Hour (hr) | 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 |
|
|
|
| Secondary | PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon | All enrolled participants with evaluable PK data. | Posted | Mean | Standard Deviation | picograms per millilitre (pg/mL) | 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 |
|
|
|
| Secondary | Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours | All enrolled participants with evaluable PD data. | Posted | Mean | Standard Deviation | Hour*millimoles per liter(hr*mmol/L) | 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 |
|
|
|
| Secondary | PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | All enrolled participants with evaluable PD data. | Posted | Median | Full Range | Millimoles per liter (mmol/L) | 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 |
|
|
|
| Secondary | PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) of Baseline-Adjusted Glucose | All enrolled participants with evaluable PD data. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | 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 |
|
|
|
| 0 |
| 18 |
| 18 |
| 18 |
| EG001 | NG - Symptom-Free | Dose of 3 mg nasal glucagon (NG) administered once in participants who have recovered from a common cold. | 0 | 17 | 17 | 17 |
| EG002 | NG - Common Cold+Oxymetazoline | Dose of 3 mg nasal glucagon (NG) administered once in participants with a common cold who are taking oxymetazoline. | 0 | 18 | 18 | 18 |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Administration site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sensation of pressure | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Administration related reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vision blurred | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Self-induced vomiting | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |