Trial Outcomes & Findings for A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults (NCT NCT02778113)
NCT ID: NCT02778113
Last Updated: 2019-09-19
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, 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
16 participants
Primary outcome timeframe
Baseline through Study Completion (Day 23)
Results posted on
2019-09-19
Participant Flow
This was a four-period crossover study in which participants received a single dose of study drug in each period, with seven days between each dose.
Participant milestones
| Measure |
Sequence 1 (T1/T2/T3/T4)
Treatment (T1) = nasal glucagon (NG) dose of 0.5 milligram (mg), T2 = NG dose of 1 mg, T3 = NG dose of 2 mg, T4 = subcutaneous (SC) glucagon dose of 1 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
|
Sequence 2 (T2/T3/T4/T1)
T2 = NG dose of 1 mg, T3 = NG dose of 2 mg, T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
|
Sequence 3 (T3/T4/T1/T2)
T3 = NG dose of 2 mg, T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg, T2 = NG dose of 1 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
|
Sequence 4 (T4/T1/T2/T3)
T4 = SC glucagon dose of 1 mg, T1 = NG dose of 0.5 mg, T2 = NG dose of 1 mg, T3 = NG dose of 2 mg. In each of four study periods, a single dose of NG was administered or SC glucagon was administered.
|
|---|---|---|---|---|
|
Study Period One
STARTED
|
4
|
4
|
4
|
4
|
|
Study Period One
Received Study Drug
|
4
|
4
|
4
|
4
|
|
Study Period One
COMPLETED
|
4
|
4
|
4
|
4
|
|
Study Period One
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Period Two
STARTED
|
4
|
4
|
4
|
4
|
|
Study Period Two
Received Study Drug
|
4
|
4
|
4
|
4
|
|
Study Period Two
COMPLETED
|
4
|
4
|
4
|
4
|
|
Study Period Two
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Period Three
STARTED
|
4
|
4
|
3
|
4
|
|
Study Period Three
Received Study Drug
|
4
|
4
|
3
|
4
|
|
Study Period Three
COMPLETED
|
4
|
4
|
3
|
4
|
|
Study Period Three
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Period Four
STARTED
|
3
|
4
|
2
|
4
|
|
Study Period Four
Received Study Drug
|
3
|
4
|
2
|
4
|
|
Study Period Four
COMPLETED
|
3
|
4
|
2
|
4
|
|
Study Period Four
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
Baseline characteristics by cohort
| Measure |
All Participants
n=16 Participants
In each of four study periods, a single dose of either NG or SC glucagon was administered.
|
|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Completion (Day 23)Population: All randomized participants who entered study period four.
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, 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 0.5 mg
n=15 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=14 Participants
NG dose of 1 mg.
|
NG 2 mg
n=16 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 picogram per milliliter \[pg/mL\]) except for one participant at one time point.
Outcome measures
| Measure |
NG 0.5 mg
n=1 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=7 Participants
NG dose of 1 mg.
|
NG 2 mg
n=15 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
|
NA picogram*hour per milliliter (pg*h/mL)
Geometric Coefficient of Variation NA
n=1. Individual value was 4.42 pg\*h/ml.
|
38.9 picogram*hour per milliliter (pg*h/mL)
Geometric Coefficient of Variation 483
|
293 picogram*hour per milliliter (pg*h/mL)
Geometric Coefficient of Variation 172
|
2060 picogram*hour per milliliter (pg*h/mL)
Geometric Coefficient of Variation 68
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PK data. AUC(0-inf) could not be calculated for the NG 0.5 mg arm, because all participants had serum glucagon levels below the lower limit of quantification (100 pg/mL) except for one participant at one time point.
Outcome measures
| Measure |
NG 0.5 mg
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=1 Participants
NG dose of 1 mg.
|
NG 2 mg
n=5 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=14 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
|
—
|
NA pg*h/mL
Geometric Coefficient of Variation NA
n=1. Individual value was 323 pg\*h/mL.
|
589 pg*h/mL
Geometric Coefficient of Variation 50
|
2250 pg*h/mL
Geometric Coefficient of Variation 66
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 pg/mL) except for one participant at one time point.
Outcome measures
| Measure |
NG 0.5 mg
n=1 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=7 Participants
NG dose of 1 mg.
|
NG 2 mg
n=15 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
|
0.17 hour (h)
Interval 0.17 to 0.17
|
0.25 hour (h)
Interval 0.17 to 0.28
|
0.25 hour (h)
Interval 0.17 to 0.67
|
0.33 hour (h)
Interval 0.11 to 0.67
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 pg/mL) except for one participant at one time point.
Outcome measures
| Measure |
NG 0.5 mg
n=1 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=7 Participants
NG dose of 1 mg.
|
NG 2 mg
n=15 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
|
NA picogram per milliliter (pg/mL)
Geometric Coefficient of Variation NA
n=1. Individual value was 52.0 pg/mL.
|
217 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 231
|
1000 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 104
|
3260 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 59
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PD data.
Outcome measures
| Measure |
NG 0.5 mg
n=15 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=14 Participants
NG dose of 1 mg.
|
NG 2 mg
n=16 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose
|
-0.168 millimole*hour per liter (mmol*h/L)
Standard Error 0.202
|
0.0617 millimole*hour per liter (mmol*h/L)
Standard Error 0.177
|
0.566 millimole*hour per liter (mmol*h/L)
Standard Error 0.324
|
0.448 millimole*hour per liter (mmol*h/L)
Standard Error 0.490
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PD data.
Outcome measures
| Measure |
NG 0.5 mg
n=15 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=14 Participants
NG dose of 1 mg.
|
NG 2 mg
n=16 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
|
0.33 hour (h)
Interval 0.17 to 0.67
|
0.36 hour (h)
Interval 0.25 to 0.5
|
0.50 hour (h)
Interval 0.33 to 0.67
|
0.37 hour (h)
Interval 0.25 to 0.67
|
SECONDARY outcome
Timeframe: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatmentPopulation: All randomized participants with evaluable PD data.
Outcome measures
| Measure |
NG 0.5 mg
n=15 Participants
Nasal glucagon (NG) dose of 0.5 milligram (mg).
|
NG 1 mg
n=14 Participants
NG dose of 1 mg.
|
NG 2 mg
n=16 Participants
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 Participants
Subcutaneous (SC) glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
|
0.811 millimole per liter (mmol/L)
Standard Error 0.119
|
1.92 millimole per liter (mmol/L)
Standard Error 0.173
|
3.20 millimole per liter (mmol/L)
Standard Error 0.252
|
3.28 millimole per liter (mmol/L)
Standard Error 0.326
|
Adverse Events
NG 0.5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
NG 1 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
NG 2 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SC Glucagon 1 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NG 0.5 mg
n=15 participants at risk
NG dose of 0.5 mg.
|
NG 1 mg
n=14 participants at risk
NG dose of 1 mg.
|
NG 2 mg
n=16 participants at risk
NG dose of 2 mg.
|
SC Glucagon 1 mg
n=15 participants at risk
SC glucagon dose of 1 mg.
|
|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
14.3%
2/14 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
12.5%
2/16 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
7.1%
1/14 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
18.8%
3/16 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
40.0%
6/15 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
20.0%
3/15 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Asthenia
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
7.1%
1/14 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Feeling cold
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Injection site pain
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Injection site reaction
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
20.0%
3/15 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Injury, poisoning and procedural complications
Vessel puncture site haematoma
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Injury, poisoning and procedural complications
Vessel puncture site reaction
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
13.3%
2/15 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
14.3%
2/14 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Nervous system disorders
Somnolence
|
13.3%
2/15 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
14.3%
2/14 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
12.5%
2/16 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
13.3%
2/15 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
7.1%
1/14 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/14 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.2%
1/16 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
21.4%
3/14 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
25.0%
4/16 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
21.4%
3/14 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
18.8%
3/16 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
7.1%
1/14 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
28.6%
4/14 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
25.0%
4/16 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
7.1%
1/14 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
6.7%
1/15 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
7.1%
1/14 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/16 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
0.00%
0/15 • First dose of study drug (Day 1) until post-study completion (Day 23)
All randomized participants who entered study period four.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60