Trial Outcomes & Findings for A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects (NCT NCT02648438)
NCT ID: NCT02648438
Last Updated: 2017-06-15
Results Overview
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
COMPLETED
PHASE1
30 participants
0-96 hours
2017-06-15
Participant Flow
This study was conducted at PAREXEL International, Early Phase Clinical Unit, Baltimore, United States of America. A total of 30 subjects were enrolled in the study and Twenty-four subjects completed the study.
The IV infusion was fixed as the first treatment (Period 1), the monodose inhaler was fixed as the second treatment (Period 2) and the oral formulation was fixed as the fourth treatment (Period 4). During Period 3, subjects were split into 2 equal cohorts, multiple-dose DPI and pMDI.
Participant milestones
| Measure |
IV, DPI 1, DPI 2, Oral
IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
|
IV, DPI 1, pMDI, Oral
IV formulation, monodose inhaler, pMDI, oral formulation
|
pMDI (Additional)
Pressurized metered-dose inhaler (pMDI)
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
6
|
|
Overall Study
COMPLETED
|
9
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
IV, DPI 1, DPI 2, Oral
IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
|
IV, DPI 1, pMDI, Oral
IV formulation, monodose inhaler, pMDI, oral formulation
|
pMDI (Additional)
Pressurized metered-dose inhaler (pMDI)
|
|---|---|---|---|
|
Overall Study
Eligibility criteria not fulfilled
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
IV, DPI 1, DPI 2, Oral
n=12 Participants
IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
|
IV, DPI 1, pMDI, Oral
n=12 Participants
IV formulation, monodose inhaler, pMDI, oral formulation
|
pMDI (Additional)
n=6 Participants
Pressurized metered-dose inhaler (pMDI)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.3 Years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
31.3 Years
STANDARD_DEVIATION 4.58 • n=7 Participants
|
35.5 Years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
32.9 Years
STANDARD_DEVIATION 5.56 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=1 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=1 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
n=10 Participants
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
n=6 Participants
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)
|
27.49 Percentage
Geometric Coefficient of Variation NA
Insufficient number of participants for CV%.
|
30.73 Percentage
Geometric Coefficient of Variation NA
Insufficient number of participants for CV%.
|
NA Percentage
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
NA Percentage
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=24 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=1 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)
|
NA Percentage
Geometric Coefficient of Variation NA
The Fpo is calculated only after oral administration hence not applicable for IV administration.
|
0.4543 Percentage
Geometric Coefficient of Variation NA
The Fpo could not be calculated because the plasma levels after oral administration were so low, they could not be quantified.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=23 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=9 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
n=3 Participants
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
n=3 Participants
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
n=24 Participants
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
n=2 Participants
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax)
|
112.6 pmol/L
Geometric Coefficient of Variation 28.42
|
68.88 pmol/L
Geometric Coefficient of Variation 22.16
|
13.93 pmol/L
Geometric Coefficient of Variation 25.73
|
15.47 pmol/L
Geometric Coefficient of Variation 11.34
|
6598 pmol/L
Geometric Coefficient of Variation 27.05
|
19.31 pmol/L
Geometric Coefficient of Variation 19.90
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=23 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=9 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
n=1 Participants
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
n=3 Participants
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
n=24 Participants
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
n=1 Participants
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)
|
2524 (h*pmol/L)
Geometric Coefficient of Variation 45.16
|
2648 (h*pmol/L)
Geometric Coefficient of Variation 23.13
|
42.93 (h*pmol/L)
Geometric Coefficient of Variation NA
Not applicable as n=1
|
572.7 (h*pmol/L)
Geometric Coefficient of Variation 83.69
|
3343 (h*pmol/L)
Geometric Coefficient of Variation 19.69
|
110.1 (h*pmol/L)
Geometric Coefficient of Variation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=23 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=9 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
n=1 Participants
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
n=6 Participants
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total)
|
28.21 Percentage
Geometric Coefficient of Variation 45.38
|
30.92 Percentage
Geometric Coefficient of Variation 20.87
|
0.3560 Percentage
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
NA Percentage
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=1 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=1 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
n=10 Participants
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
n=6 Participants
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
Oral Bioavailability After Inhaled Treatment (F Oral)
|
0.3294 Percentage
Geometric Coefficient of Variation NA
Not applicable as n=1
|
0.3147 Percentage
Geometric Coefficient of Variation NA
Not applicable as n=1
|
NA Percentage
Geometric Coefficient of Variation NA
F oral was not calculated for the additional pMDI cohort as this cohort did not receive the oral and IV formulation treatments.
|
NA Percentage
Geometric Coefficient of Variation NA
F oral was not calculated for the additional pMDI cohort as this cohort did not receive the oral and IV formulation treatments.
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-96 hoursPopulation: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Outcome measures
| Measure |
400 µg DPI Device 1
n=23 Participants
AZD7594 400 μg delivered dose via Monodose inhaler
|
400 µg DPI Device 2
n=9 Participants
AZD7594 400 μg delivered dose via Multiple dose inhaler
|
400 µg pMDI
n=10 Participants
AZD7594 400 μg delivered dose pMDI
|
400 µg pMDI (Additional)
n=6 Participants
AZD7594 400 μg delivered dose pMDI (Separate treatment)
|
150 µg IV Formulation
n=24 Participants
AZD7594 150 µg IV formulation
|
1200 µg Oral Formulation
n=9 Participants
AZD7594 1200 μg oral formulation
|
|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC)
|
NA (h*pmol/L)
Geometric Coefficient of Variation NA
Not reported since parameter cannot be calculated as per standard criteria.
|
NA (h*pmol/L)
Geometric Coefficient of Variation NA
Not reported since parameter cannot be calculated as per standard criteria.
|
NA (h*pmol/L)
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
NA (h*pmol/L)
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
3465 (h*pmol/L)
Geometric Coefficient of Variation 19.44
|
NA (h*pmol/L)
Geometric Coefficient of Variation NA
Plasma levels were too low to be detected hence not calculated.
|
Adverse Events
IV Formulation
DPI Device 1
DPI Device 2
pMDI
Oral Formulation
pMDI (Additional)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Formulation
n=24 participants at risk
AZD7594 150 μg IV formulation
|
DPI Device 1
n=23 participants at risk
AZD7594 400 μg delivered dose monodose inhaler
|
DPI Device 2
n=9 participants at risk
AZD7594 400 μg delivered dose multiple-dose DPI
|
pMDI
n=10 participants at risk
AZD7594 400 μg delivered dose pMDI
|
Oral Formulation
n=18 participants at risk
AZD7594 1200 μg oral formulation
|
pMDI (Additional)
n=6 participants at risk
AZD7594 400 μg delivered dose pMDI (separate treatment)
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
10.0%
1/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
16.7%
1/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
|
Eye disorders
Ocular hyperemia
|
0.00%
0/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
5.6%
1/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
|
General disorders
Infusion site pain
|
4.2%
1/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
11.1%
1/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
|
Injury, poisoning and procedural complications
Traumatic hematoma
|
4.2%
1/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
1/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/23 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
11.1%
1/9 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/10 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/18 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
0.00%
0/6 • Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).
There were no deaths or SAEs reported in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER