Trial Outcomes & Findings for A Study of Nasal Glucagon in Participants With a Common Cold (NCT NCT02778100)
NCT ID: NCT02778100
Last Updated: 2019-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Baseline up to Study Completion (Day 30)
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
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.
|
NG 3 mg Plus Oxymetazoline
Period 1 only: NG administered once to participants with a common cold, who are taking oxymetazoline.
|
|---|---|---|
|
Period 1 (Common Cold)
STARTED
|
18
|
18
|
|
Period 1 (Common Cold)
COMPLETED
|
17
|
18
|
|
Period 1 (Common Cold)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (No Cold Symptoms)
STARTED
|
17
|
0
|
|
Period 2 (No Cold Symptoms)
COMPLETED
|
17
|
0
|
|
Period 2 (No Cold Symptoms)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
NG 3 mg Plus Oxymetazoline
Period 1 only: NG administered once to participants with a common cold, who are taking oxymetazoline.
|
|---|---|---|
|
Period 1 (Common Cold)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Nasal Glucagon in Participants With a Common Cold
Baseline characteristics by cohort
| Measure |
Nasal Glucagon (NG)
n=18 Participants
Dose of 3 mg NG administered once to participants with a common cold.
|
NG Plus Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once to participants with a common cold, who are taking oxymetazoline.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
29 years
n=7 Participants
|
30.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Study Completion (Day 30)Population: All enrolled participants.
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.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
|
1039.7 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 1020.81
|
631.8 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 399.66
|
868.4 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 622.39
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
|
1108.9 pg*hr/mL
Standard Deviation 1055
|
669.3 pg*hr/mL
Standard Deviation 431.7
|
1064.3 pg*hr/mL
Standard Deviation 838.4
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
|
0.3 Hour (hr)
Interval 0.08 to 1.5
|
0.3 Hour (hr)
Interval 0.25 to 0.67
|
0.3 Hour (hr)
Interval 0.17 to 1.0
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
|
1145.4 picograms per millilitre (pg/mL)
Standard Deviation 994.43
|
745.6 picograms per millilitre (pg/mL)
Standard Deviation 548.42
|
811.5 picograms per millilitre (pg/mL)
Standard Deviation 597.51
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PD data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours
|
4.3 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 2.11
|
3.8 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 1.92
|
4.2 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PD data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
|
0.5 Millimoles per liter (mmol/L)
Interval 0.25 to 1.0
|
0.6 Millimoles per liter (mmol/L)
Interval 0.33 to 1.0
|
0.7 Millimoles per liter (mmol/L)
Interval 0.33 to 1.0
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: All enrolled participants with evaluable PD data.
Outcome measures
| Measure |
NG - Common Cold
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 Participants
Dose of 3 mg NG administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 Participants
Dose of 3 mg NG administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) of Baseline-Adjusted Glucose
|
2.9 Millimoles per liter (mmol/L)
Standard Deviation 1.57
|
2.7 Millimoles per liter (mmol/L)
Standard Deviation 1.38
|
3.4 Millimoles per liter (mmol/L)
Standard Deviation 1.42
|
Adverse Events
NG- Common Cold
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
NG - Symptom-Free
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
NG - Common Cold+Oxymetazoline
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NG- Common Cold
n=18 participants at risk
Dose of 3 mg nasal glucagon (NG) administered once in participants with a common cold.
|
NG - Symptom-Free
n=17 participants at risk
Dose of 3 mg nasal glucagon (NG) administered once in participants who have recovered from a common cold.
|
NG - Common Cold+Oxymetazoline
n=18 participants at risk
Dose of 3 mg nasal glucagon (NG) administered once in participants with a common cold who are taking oxymetazoline.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Eye disorders
Eye pruritus
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Eye disorders
Eye swelling
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Eye disorders
Lacrimation increased
|
72.2%
13/18 • Number of events 17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
70.6%
12/17 • Number of events 13 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
66.7%
12/18 • Number of events 16 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Eye disorders
Ocular hyperaemia
|
38.9%
7/18 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
41.2%
7/17 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
44.4%
8/18 • Number of events 12 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Gastrointestinal disorders
Nausea
|
44.4%
8/18 • Number of events 10 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
11.8%
2/17 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
38.9%
7/18 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
27.8%
5/18 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Administration site reaction
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Asthenia
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Facial pain
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Fatigue
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Feeling cold
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Feeling hot
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
General disorders
Sensation of pressure
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Investigations
Blood glucose decreased
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Investigations
Neutrophil count increased
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Investigations
White blood cell count increased
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Disturbance in attention
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Dizziness
|
22.2%
4/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
29.4%
5/17 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
17.6%
3/17 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Parosmia
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Somnolence
|
33.3%
6/18 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
17.6%
3/17 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Tremor
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Nervous system disorders
Vision blurred
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Psychiatric disorders
Self-induced vomiting
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
17.6%
3/17 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
22.2%
4/18 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
66.7%
12/18 • Number of events 15 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
41.2%
7/17 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
83.3%
15/18 • Number of events 15 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
55.6%
10/18 • Number of events 10 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
29.4%
5/17 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
77.8%
14/18 • Number of events 15 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
27.8%
5/18 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
17.6%
3/17 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
16.7%
3/18 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.9%
1/17 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
5.6%
1/18 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
|
Vascular disorders
Hot flush
|
11.1%
2/18 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/17 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
0.00%
0/18 • First dose of study drug (Day 1) until post-study completion (Day 30).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60