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Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02968914
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Asthma
Chronic Obstructive Pulmonary Disease
Intervention Biological: Benralizumab
Enrollment 180
Recruitment Details Subjects who met all the inclusion and none of the exclusion criteria were enrolled at PAREXEL Early Phase Clinical Unit in Berlin and London.
Pre-assignment Details Subjects attended a Screening Visit within 28 days before receiving their first dose of Benralizumab. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.
Arm/Group Title Benralizumab 30mg Autoinjector (AI) Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
Hide Arm/Group Description All randomized subjects received 30mg Benralizumab by AI under fasted conditions. All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Period Title: Overall Study
Started 90 90
Completed 90 90
Not Completed 0 0
Arm/Group Title Benralizumab 30mg Autoinjector (AI) Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS) Total
Hide Arm/Group Description All randomized subjects received 30mg Benralizumab by AI under fasted conditions. All randomized subjects received 30mg Benralizumab by APFS under fasted conditions. Total of all reporting groups
Overall Number of Baseline Participants 90 90 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 90 participants 180 participants
40.8  (10.8) 41.1  (11.1) 40.9  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
Female
17
  18.9%
16
  17.8%
33
  18.3%
Male
73
  81.1%
74
  82.2%
147
  81.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
Hispanic or Latino
1
   1.1%
2
   2.2%
3
   1.7%
Not Hispanic or Latino
89
  98.9%
88
  97.8%
177
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.2%
3
   3.3%
5
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   5.6%
5
   5.6%
10
   5.6%
White
83
  92.2%
80
  88.9%
163
  90.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   2.2%
2
   1.1%
1.Primary Outcome
Title Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)
Hide Description To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 88 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day·ng/mL
72210
(29.7%)
76220
(32.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg AI, Benralizumab 30mg AFPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 94.46
Confidence Interval (2-Sided) 90%
88.16 to 101.21
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Hide Description To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 90 90
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day·ng/mL
60560
(27.3%)
65230
(29.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg AI, Benralizumab 30mg AFPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 92.83
Confidence Interval (2-Sided) 90%
87.41 to 98.58
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Observed Concentration (Cmax)
Hide Description To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 90 90
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2096
(32.7%)
2269
(35.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benralizumab 30mg AI, Benralizumab 30mg AFPS
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 92.34
Confidence Interval (2-Sided) 90%
86.34 to 98.75
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time When Maximum Concentration is Observed (Tmax)
Hide Description To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 90 90
Median (Full Range)
Unit of Measure: Days
Abdomen 55.0 to 69.9 kg Number Analyzed 10 participants 10 participants
4.59
(2.97 to 7.04)
6.06
(4.00 to 14.00)
Abdomen 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
6.98
(3.98 to 14.00)
5.98
(2.95 to 14.05)
Abdomen 85.0 to 100.0 kg Number Analyzed 10 participants 10 participants
5.06
(3.95 to 7.11)
6.96
(3.99 to 7.10)
Thigh 55.0 to 69.9 kg Number Analyzed 10 participants 10 participants
4.00
(2.97 to 7.01)
4.52
(2.94 to 7.04)
Thigh 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
4.05
(2.98 to 6.90)
3.52
(2.95 to 7.12)
Thigh 85.0 to 100.0 kg Number Analyzed 10 participants 10 participants
4.59
(2.94 to 13.95)
4.03
(2.98 to 6.98)
Upper arm 55.0 to 69.9 kg Number Analyzed 10 participants 10 participants
6.97
(3.97 to 14.02)
4.96
(3.02 to 14.04)
Upper arm 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
7.00
(5.01 to 14.03)
5.02
(2.99 to 8.01)
Upper arm 85.0 to 100.0 kg Number Analyzed 10 participants 10 participants
7.00
(3.09 to 14.03)
6.97
(1.02 to 14.13)
5.Secondary Outcome
Title Terminal Half-life (t½)
Hide Description To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 88 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Days
Abdomen 55.0 to 69.9 kg Number Analyzed 10 participants 9 participants
18.83
(24.9%)
20.15
(21.8%)
Abdomen 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
20.22
(21.0%)
17.43
(21.7%)
Abdomen 85.0 to 100.0 kg Number Analyzed 10 participants 10 participants
19.59
(19.9%)
21.04
(21.7%)
Thigh 55.0 to 69.9 kg Number Analyzed 10 participants 10 participants
18.58
(20.6%)
19.72
(21.4%)
Thigh 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
19.93
(23.4%)
18.28
(17.9%)
Thigh 85.0 to 100.0 kg Number Analyzed 9 participants 10 participants
19.02
(19.9%)
17.30
(11.5%)
Upper arm 55.0 to 69.9 kg Number Analyzed 10 participants 8 participants
22.46
(13.6%)
17.30
(26.9%)
Upper arm 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
20.54
(14.0%)
20.16
(25.3%)
Upper arm 85.0 to 100.0 kg Number Analyzed 9 participants 10 participants
19.01
(26.9%)
19.42
(26.3%)
6.Secondary Outcome
Title Apparent Extravascular Clearance (CL/F)
Hide Description To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 88 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/day
Abdomen 55.0 to 69.9 kg Number Analyzed 10 participants 9 participants
388.8
(34.3%)
388.9
(43.8%)
Abdomen 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
462.9
(29.5%)
508.9
(33.2%)
Abdomen 85.0 to 100.0 kg Number Analyzed 10 participants 10 participants
504.6
(18.3%)
402.7
(30.4%)
Thigh 55.0 to 69.9 kg Number Analyzed 10 participants 10 participants
350.1
(32.6%)
281.1
(16.8%)
Thigh 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
393.7
(29.6%)
325.9
(18.2%)
Thigh 85.0 to 100.0 kg Number Analyzed 9 participants 10 participants
378.2
(26.8%)
406.0
(22.9%)
Upper arm 55.0 to 69.9 kg Number Analyzed 10 participants 8 participants
345.8
(24.7%)
455.2
(29.8%)
Upper arm 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
429.4
(19.5%)
366.1
(27.0%)
Upper arm 85.0 to 100.0 kg Number Analyzed 9 participants 10 participants
532.6
(21.7%)
471.6
(20.3%)
7.Secondary Outcome
Title Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)
Hide Description To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.
Time Frame At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 88 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
Abdomen 55.0 to 69.9 kg Number Analyzed 10 participants 9 participants
10.56
(28.0%)
11.30
(28.4%)
Abdomen 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
13.50
(30.4%)
12.79
(25.5%)
Abdomen 85.0 to 100.0 kg Number Analyzed 10 participants 10 participants
14.26
(25.0%)
12.22
(15.8%)
Thigh 55.0 to 69.9 kg Number Analyzed 10 participants 10 participants
9.386
(18.2%)
7.999
(15.5%)
Thigh 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
11.32
(23.5%)
8.596
(13.5%)
Thigh 85.0 to 100.0 kg Number Analyzed 9 participants 10 participants
10.38
(20.2%)
10.13
(21.0%)
Upper arm 55.0 to 69.9 kg Number Analyzed 10 participants 8 participants
11.21
(21.2%)
11.36
(17.7%)
Upper arm 70.0 to 84.9 kg Number Analyzed 10 participants 10 participants
12.72
(23.6%)
10.65
(18.7%)
Upper arm 85.0 to 100.0 kg Number Analyzed 9 participants 10 participants
14.61
(23.0%)
13.21
(32.9%)
8.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description To evaluate safety and tolerability of Benralizumab
Time Frame At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 90 90
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
50
  55.6%
46
  51.1%
Death
0
   0.0%
0
   0.0%
Any SAE
0
   0.0%
0
   0.0%
Any AE leading to discontinuation
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Antidrug Antibody (ADA) Status
Hide Description To evaluate the immunogenicity of Benralizumab
Time Frame At predose (Day 1), Days 29 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.
Arm/Group Title Benralizumab 30mg AI Benralizumab 30mg AFPS
Hide Arm/Group Description:
All randomized subjects received 30mg Benralizumab by AI under fasted conditions.
All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
Overall Number of Participants Analyzed 90 90
Measure Type: Count of Participants
Unit of Measure: Participants
ADA prevalence (positive at any visit)
2
   2.2%
6
   6.7%
ADA incidence
0
   0.0%
3
   3.3%
Time Frame At pre-dose and 2 h post-dose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benralizumab 30mg Autoinjector (AI) Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
Hide Arm/Group Description All randomized subjects received 30mg Benralizumab by AI under fasted conditions. All randomized subjects received 30mg Benralizumab by APFS under fasted conditions.
All-Cause Mortality
Benralizumab 30mg Autoinjector (AI) Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/90 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Benralizumab 30mg Autoinjector (AI) Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/90 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Benralizumab 30mg Autoinjector (AI) Benralizumab 30mg Accessorized Pre-filled Syringe (AFPS)
Affected / at Risk (%) Affected / at Risk (%)
Total   50/90 (55.56%)   46/90 (51.11%) 
Cardiac disorders     
Cardiovascular symptom *  0/90 (0.00%)  1/90 (1.11%) 
Palpitations *  0/90 (0.00%)  1/90 (1.11%) 
Ear and labyrinth disorders     
Ear pain *  1/90 (1.11%)  0/90 (0.00%) 
Excessive cerumen production *  0/90 (0.00%)  1/90 (1.11%) 
Eye disorders     
Eye pruritus *  1/90 (1.11%)  0/90 (0.00%) 
Eye swelling *  0/90 (0.00%)  1/90 (1.11%) 
Ocular hyperaemia *  0/90 (0.00%)  1/90 (1.11%) 
Gastrointestinal disorders     
Toothache *  4/90 (4.44%)  3/90 (3.33%) 
Abdominal pain *  1/90 (1.11%)  2/90 (2.22%) 
Nausea *  2/90 (2.22%)  1/90 (1.11%) 
Vomiting *  3/90 (3.33%)  0/90 (0.00%) 
Diarrhoea *  1/90 (1.11%)  1/90 (1.11%) 
Abdominal discomfort *  1/90 (1.11%)  0/90 (0.00%) 
Abdominal pain upper *  0/90 (0.00%)  1/90 (1.11%) 
Dyspepsia *  1/90 (1.11%)  0/90 (0.00%) 
Frequent bowel movements *  0/90 (0.00%)  1/90 (1.11%) 
General disorders     
Fatigue *  5/90 (5.56%)  1/90 (1.11%) 
Influenza like illness *  1/90 (1.11%)  1/90 (1.11%) 
Asthenia *  0/90 (0.00%)  1/90 (1.11%) 
Discomfort *  0/90 (0.00%)  1/90 (1.11%) 
Feeling hot *  1/90 (1.11%)  0/90 (0.00%) 
Injection site hypersensitivity *  1/90 (1.11%)  0/90 (0.00%) 
Pyrexia *  1/90 (1.11%)  0/90 (0.00%) 
Immune system disorders     
Seasonal allergy *  0/90 (0.00%)  1/90 (1.11%) 
Infections and infestations     
Nasopharyngitis *  18/90 (20.00%)  13/90 (14.44%) 
Rhinitis *  2/90 (2.22%)  0/90 (0.00%) 
Gingivitis *  1/90 (1.11%)  0/90 (0.00%) 
Myringitis *  0/90 (0.00%)  1/90 (1.11%) 
Tonsillitis *  0/90 (0.00%)  1/90 (1.11%) 
Injury, poisoning and procedural complications     
Sunburn *  2/90 (2.22%)  1/90 (1.11%) 
Limb injury *  1/90 (1.11%)  1/90 (1.11%) 
Traumatic haematoma *  1/90 (1.11%)  0/90 (0.00%) 
Investigations     
Body temperature increased *  0/90 (0.00%)  1/90 (1.11%) 
Metabolism and nutrition disorders     
Decreased appetite *  1/90 (1.11%)  0/90 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain *  3/90 (3.33%)  1/90 (1.11%) 
Arthralgia *  2/90 (2.22%)  0/90 (0.00%) 
Neck pain *  1/90 (1.11%)  1/90 (1.11%) 
Muscle spasms *  0/90 (0.00%)  1/90 (1.11%) 
Muscle tightness *  0/90 (0.00%)  1/90 (1.11%) 
Musculoskeletal chest pain *  0/90 (0.00%)  1/90 (1.11%) 
Musculoskeletal pain *  0/90 (0.00%)  1/90 (1.11%) 
Pain in extremity *  1/90 (1.11%)  0/90 (0.00%) 
Periarthritis *  1/90 (1.11%)  0/90 (0.00%) 
Tendon discomfort *  0/90 (0.00%)  1/90 (1.11%) 
Nervous system disorders     
Headache *  14/90 (15.56%)  5/90 (5.56%) 
Dizziness *  2/90 (2.22%)  0/90 (0.00%) 
Disturbance in attention *  0/90 (0.00%)  1/90 (1.11%) 
Hypertonia *  0/90 (0.00%)  1/90 (1.11%) 
Syncope *  1/90 (1.11%)  0/90 (0.00%) 
Tension headache *  1/90 (1.11%)  0/90 (0.00%) 
Psychiatric disorders     
Insomnia *  0/90 (0.00%)  1/90 (1.11%) 
Listless *  1/90 (1.11%)  0/90 (0.00%) 
Sleep disorder *  1/90 (1.11%)  0/90 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain *  7/90 (7.78%)  11/90 (12.22%) 
Cough *  1/90 (1.11%)  5/90 (5.56%) 
Dyspnoea *  0/90 (0.00%)  2/90 (2.22%) 
Nasal dryness *  0/90 (0.00%)  1/90 (1.11%) 
Rhinorrhoea *  0/90 (0.00%)  1/90 (1.11%) 
Skin and subcutaneous tissue disorders     
Acne *  2/90 (2.22%)  2/90 (2.22%) 
Rash *  1/90 (1.11%)  0/90 (0.00%) 
Skin fissures *  1/90 (1.11%)  0/90 (0.00%) 
Vascular disorders     
Haematoma *  2/90 (2.22%)  2/90 (2.22%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AstraZeneca Clinical Study Information Center
Organization: AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02968914     History of Changes
Other Study ID Numbers: D3250C00030
First Submitted: October 28, 2016
First Posted: November 21, 2016
Results First Submitted: January 2, 2019
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019