Trial Outcomes & Findings for A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes (NCT NCT02806973)
NCT ID: NCT02806973
Last Updated: 2019-10-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
Results posted on
2019-10-14
Participant Flow
Participant milestones
| Measure |
Sequence 1 (T1/T2/T3/T4)
Treatment 1 (T1) = Single NG dose of 3 milligram (mg), T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
|
Sequence 2 (T2/T3/T4/T1)
T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later , T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg.
|
Sequence 3 (T3/T4/T1/T2)
T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
|
Sequence 4 (T4/T1/T2/T3)
T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
6
|
7
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
2
|
1
|
2
|
|
Period 2
STARTED
|
8
|
6
|
7
|
6
|
|
Period 2
COMPLETED
|
8
|
6
|
7
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
8
|
6
|
7
|
6
|
|
Period 3
COMPLETED
|
8
|
6
|
6
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
1
|
3
|
|
Period 4
STARTED
|
8
|
6
|
6
|
3
|
|
Period 4
COMPLETED
|
8
|
6
|
6
|
3
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 (T1/T2/T3/T4)
Treatment 1 (T1) = Single NG dose of 3 milligram (mg), T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
|
Sequence 2 (T2/T3/T4/T1)
T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later , T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg.
|
Sequence 3 (T3/T4/T1/T2)
T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
|
Sequence 4 (T4/T1/T2/T3)
T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
2
|
1
|
1
|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
1
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
|
Period 3
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes
Baseline characteristics by cohort
| Measure |
Nasal Glucagon
n=32 Participants
All enrolled participants.
|
|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon
|
2470 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 1850
|
4100 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 1760
|
4640 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 2400
|
3610 picogram*hour per millilitre (pg*hr/mL)
Standard Deviation 1880
|
PRIMARY outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
|
0.17 Hour (hr)
Interval 0.17 to 0.75
|
0.33 Hour (hr)
Interval 0.17 to 0.5
|
0.50 Hour (hr)
Interval 0.17 to 0.5
|
0.33 Hour (hr)
Interval 0.17 to 0.33
|
PRIMARY outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
|
4960 picograms per millilitre (pg/mL)
Standard Deviation 3700
|
7140 picograms per millilitre (pg/mL)
Standard Deviation 3270
|
8080 picograms per millilitre (pg/mL)
Standard Deviation 4170
|
6650 picograms per millilitre (pg/mL)
Standard Deviation 3640
|
PRIMARY outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PD data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours
|
157 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 95.7
|
168 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 99.3
|
190 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 95.3
|
194 Hour*millimoles per liter(hr*mmol/L)
Standard Deviation 117
|
PRIMARY outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PD data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
|
0.75 Hour (hr)
Interval 0.5 to 1.5
|
1.00 Hour (hr)
Interval 0.5 to 2.5
|
1.00 Hour (hr)
Interval 0.75 to 1.75
|
1.00 Hour (hr)
Interval 0.5 to 2.5
|
PRIMARY outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PD data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
|
89.5 mmol/L
Standard Deviation 36.6
|
98.4 mmol/L
Standard Deviation 39.4
|
108 mmol/L
Standard Deviation 36.9
|
105 mmol/L
Standard Deviation 44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administrationPopulation: All enrolled participants with evaluable PK data.
Outcome measures
| Measure |
Nasal Glucagon Treatment 1
n=27 Participants
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 Participants
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 Participants
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 Participants
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Glucagon
|
2730 pg*hr/mL
Standard Deviation 1860
|
4440 pg*hr/mL
Standard Deviation 1800
|
4940 pg*hr/mL
Standard Deviation 2400
|
3900 pg*hr/mL
Standard Deviation 1920
|
Adverse Events
Nasal Glucagon Treatment 1
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Nasal Glucagon - Treatment 2
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Nasal Glucagon - Treatment 3
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Nasal Glucagon - Treatment 4
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nasal Glucagon Treatment 1
n=27 participants at risk
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 participants at risk
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 participants at risk
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 participants at risk
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
Other adverse events
| Measure |
Nasal Glucagon Treatment 1
n=27 participants at risk
One dose of nasal glucagon.
|
Nasal Glucagon - Treatment 2
n=28 participants at risk
Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
|
Nasal Glucagon - Treatment 3
n=25 participants at risk
Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.
|
Nasal Glucagon - Treatment 4
n=29 participants at risk
Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.
|
|---|---|---|---|---|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.7%
3/28 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Eye disorders
Eye irritation
|
7.4%
2/27 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
17.9%
5/28 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
8.0%
2/25 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.3%
3/29 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Eye disorders
Eye pain
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Eye disorders
Lacrimation increased
|
92.6%
25/27 • Number of events 25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
89.3%
25/28 • Number of events 38 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
92.0%
23/25 • Number of events 36 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
86.2%
25/29 • Number of events 27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Eye disorders
Ocular hyperaemia
|
7.4%
2/27 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
17.9%
5/28 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
12.0%
3/25 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.3%
3/29 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Gastrointestinal disorders
Nausea
|
14.8%
4/27 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
32.1%
9/28 • Number of events 10 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
20.0%
5/25 • Number of events 5 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
31.0%
9/29 • Number of events 9 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
25.0%
7/28 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
12.0%
3/25 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.3%
3/29 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
General disorders
Asthenia
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
General disorders
Fatigue
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
6.9%
2/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
General disorders
Feeling cold
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
General disorders
Feeling hot
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Infections and infestations
Body tinea
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Infections and infestations
Oral herpes
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Injury, poisoning and procedural complications
Eye injury
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Injury, poisoning and procedural complications
Procedural complication
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
6.9%
2/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Injury, poisoning and procedural complications
Vessel puncture site bruise
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Investigations
Blood glucose decreased
|
11.1%
3/27 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
14.3%
4/28 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
12.0%
3/25 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
13.8%
4/29 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Investigations
Blood potassium increased
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Investigations
Pulse abnormal
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Investigations
White blood cell count increased
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.7%
3/28 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
21.4%
6/28 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
12.0%
3/25 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Headache
|
33.3%
9/27 • Number of events 10 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
50.0%
14/28 • Number of events 15 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
48.0%
12/25 • Number of events 14 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
41.4%
12/29 • Number of events 12 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Paraesthesia
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
6.9%
2/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Parosmia
|
7.4%
2/27 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
12.0%
3/25 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
13.8%
4/29 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Sinus headache
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Somnolence
|
7.4%
2/27 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
13.8%
4/29 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Nervous system disorders
Tremor
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
12.0%
3/25 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
8.0%
2/25 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
6.9%
2/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
1/27 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
8.0%
2/25 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.3%
3/29 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
33.3%
9/27 • Number of events 9 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
25.0%
7/28 • Number of events 12 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
24.0%
6/25 • Number of events 8 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
34.5%
10/29 • Number of events 12 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
7.4%
2/27 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.4%
1/29 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
17.9%
5/28 • Number of events 6 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
20.0%
5/25 • Number of events 7 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
6.9%
2/29 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
8.0%
2/25 • Number of events 4 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
10.3%
3/29 • Number of events 3 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/28 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.7%
1/27 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
7.1%
2/28 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
4.0%
1/25 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Vascular disorders
Hot flush
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
8.0%
2/25 • Number of events 2 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
|
Vascular disorders
Pallor
|
0.00%
0/27 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
3.6%
1/28 • Number of events 1 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/25 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
0.00%
0/29 • First dose of study drug (Day 1) until post-study completion (Day 50)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60