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Trial record 34 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02512575
Recruitment Status : Completed
First Posted : July 31, 2015
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Conditions Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Healthy Subjects
Rheumatoid Arthritis
Interventions Drug: AZD9567 Monohydrat
Drug: Placebo oral suspension/ Placebo capsule
Drug: Prednisolone
Enrollment 72
Recruitment Details Phase 1, single-center (Berlin), randomized, single-blind, placebo-controlled study carried on 72 healthy male participants (8 subjects per cohort). In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2). Participants received treatment in a fasted state
Pre-assignment Details Screening period (Day -28 to Day -3). For Cohort 7, screening period was up to 21 days
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Hide Arm/Group Description In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
Period Title: Overall Study
Started 6 6 6 6 6 6 6 6 6 18
Completed 6 6 6 6 6 6 6 6 6 18
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo Total
Hide Arm/Group Description In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2) Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 6 6 6 18 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 72 participants
Cohort 1-8 AZD9567 44  (10) 35  (14) 35  (8) 35  (9) 38  (12) 34  (9) 41  (8) 32  (8) 0  (0) 0  (0) 37  (10)
Cohort 9 Prenisolone 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 36  (9) 0  (0) 36  (9)
Pooled Placebo 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 37  (11) 37  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 72 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
18
 100.0%
72
 100.0%
1.Primary Outcome
Title Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events
Hide Description

Safety and tolerability variables included AEs, vital signs (blood pressure and pulse), ECGs (12-lead ECGs, safety ECGs and telemetry), clinical laboratory safety evaluations (haematology, clinical chemistry [including osteocalcin], coagulation, urinalysis [including 24 hour urine cortisol per day {tU-cortisol}]) and physical examinations.

Note: No clinically relevant findings were noted in clinical laboratory results and vial signs assessments. Hence, none of the laboratory or vital signs findings were reported as AEs.

Time Frame At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study. IMP includes AZD9567, Prednisolone 60 mg and placebo.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6 6 18
Measure Type: Number
Unit of Measure: Participants
Any AE 0 0 1 0 0 2 1 0 0 3
Any AE (including events with outcome =death) 0 0 0 0 0 0 0 0 0 0
Any serious adverse event (SAE) (including death) 0 0 0 0 0 0 0 0 0 0
Any AE leading to discontinuation of AZD9567 0 0 0 0 0 0 0 0 0 0
2.Primary Outcome
Title Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Observed Maximum Plasma Concentration (Cmax)
Hide Description To assess the Cmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. Cmax was taken directly from the individual concentration-time curve.
Time Frame On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
184.9
(20.18%)
751.6
(25.03%)
1327
(17.28%)
2536
(38.33%)
4261
(13.88%)
5835
(14.14%)
6080
(21.30%)
6900
(33.97%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9567 - 2 mg, AZD9567 - 10 mg, AZD9567 - 20 mg, AZD9567 - 40 mg, AZD9567 - 80 mg, AZD9567 - 100 mg, AZD9567 - 125 mg, AZD9567 - 155 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.847
Confidence Interval (2-Sided) 90%
0.807 to 0.887
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0238
Estimation Comments [Not Specified]
3.Primary Outcome
Title Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Time to Reach Maximum Plasma Concentration(Tmax)
Hide Description To assess the tmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. tmax was taken directly from the individual concentration-time curve.
Time Frame On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: Hours
0.50
(0.48 to 0.50)
0.75
(0.27 to 1.00)
0.51
(0.50 to 1.50)
0.75
(0.50 to 1.00)
1.00
(1.00 to 1.50)
1.00
(0.50 to 1.50)
1.00
(0.50 to 1.50)
1.25
(0.58 to 2.00)
4.Primary Outcome
Title Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Terminal Half-life (t½λz)
Hide Description To assess t½λz of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. t½λz was estimated as (ln2)/λz.
Time Frame On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: Hours
4.716  (0.8182) 5.444  (2.157) 3.929  (1.237) 4.199  (1.417) 5.286  (1.469) 5.297  (1.041) 4.664  (1.052) 6.449  (1.778)
5.Primary Outcome
Title Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC(0-last))
Hide Description To assess AUC(0-last) of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state.
Time Frame On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*nmol/L
940.6
(3.46% to 5.89%)
5069
(2.70% to 9.22%)
7598
(3.13% to 6.31%)
13860
(2.28% to 6.13%)
31600
(3.50% to 6.97%)
41850
(3.89% to 7.02%)
40930
(3.49% to 6.16%)
56940
(4.64% to 8.90%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9567 - 2 mg, AZD9567 - 10 mg, AZD9567 - 20 mg, AZD9567 - 40 mg, AZD9567 - 80 mg, AZD9567 - 100 mg, AZD9567 - 125 mg, AZD9567 - 155 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.930
Confidence Interval (2-Sided) 90%
0.869 to 0.991
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0364
Estimation Comments [Not Specified]
6.Primary Outcome
Title Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC)
Hide Description To assess AUC of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. AUC was estimated by AUC(0-last) + Clast/λz. Clast - the last observed quantifiable concentration.
Time Frame On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*nmol/L
1007
(3.46% to 5.89%)
5266
(2.70% to 9.22%)
7670
(3.13% to 6.31%)
14000
(2.28% to 6.13%)
31840
(3.50% to 6.97%)
42080
(3.89% to 7.02%)
41290
(3.49% to 6.16%)
57500
(4.64% to 8.90%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9567 - 2 mg, AZD9567 - 10 mg, AZD9567 - 20 mg, AZD9567 - 40 mg, AZD9567 - 80 mg, AZD9567 - 100 mg, AZD9567 - 125 mg, AZD9567 - 155 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.917
Confidence Interval (2-Sided) 90%
0.856 to 0.978
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0364
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
Hide Description

To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of plasma glucose. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.

Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT plasma glucose total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect.

Time Frame At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamics (PD) analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6 6 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: min*mmol/L
1.04
(0.963 to 1.12)
1.01
(0.932 to 1.09)
1.07
(0.990 to 1.15)
1.06
(0.986 to 1.14)
1.08
(0.999 to 1.16)
1.17
(1.09 to 1.26)
1.16
(1.08 to 1.25)
1.20
(1.12 to 1.30)
1.19
(1.11 to 1.29)
1.01
(0.964 to 1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9567 - 2 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.960 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9567 - 10 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.929 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9567 - 20 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
0.987 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9567 - 40 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.983 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AZD9567 - 80 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.07
Confidence Interval (2-Sided) 90%
0.995 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection AZD9567 - 100 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.17
Confidence Interval (2-Sided) 90%
1.09 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection AZD9567 - 125 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.15
Confidence Interval (2-Sided) 90%
1.07 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection AZD9567 - 155 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.20
Confidence Interval (2-Sided) 90%
1.11 to 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Prednisolone - 60 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.19
Confidence Interval (2-Sided) 90%
1.11 to 1.27
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Relative Change From Baseline of AUC0-4h for Serum Insulin to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
Hide Description

To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum insulin. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.

Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum insulin total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect.

Time Frame At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6 6 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: min*pmol/L
1.19
(0.987 to 1.45)
1.20
(0.990 to 1.45)
1.03
(0.838 to 1.28)
1.04
(0.863 to 1.26)
0.999
(0.824 to 1.21)
0.980
(0.811 to 1.18)
1.15
(0.953 to 1.39)
1.16
(0.958 to 1.40)
0.784
(0.648 to 0.947)
1.14
(1.02 to 1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9567 - 2 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.872 to 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9567 - 10 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.874 to 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9567 - 20 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.907
Confidence Interval (2-Sided) 90%
0.745 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9567 - 40 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.914
Confidence Interval (2-Sided) 90%
0.762 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AZD9567 - 80 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.876
Confidence Interval (2-Sided) 90%
0.728 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection AZD9567 - 100 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.860
Confidence Interval (2-Sided) 90%
0.716 to 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection AZD9567 - 125 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.842 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection AZD9567 - 155 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 1.02
Confidence Interval (2-Sided) 90%
0.846 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Prednisolone - 60 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.687
Confidence Interval (2-Sided) 90%
0.572 to 0.825
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Relative Change From Baseline of AUC0-4h for Serum C-peptide to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
Hide Description

To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum C-peptide. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.

Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum C-peptide total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect.

Time Frame At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Hide Arm/Group Description:
In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state
In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state
In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state
In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state
In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state
In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state
In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state
In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state
In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state
In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 6 6 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: min*nmol/L
1.06
(0.929 to 1.22)
1.04
(0.913 to 1.19)
1.02
(0.895 to 1.17)
0.933
(0.816 to 1.07)
0.919
(0.804 to 1.05)
1.00
(0.879 to 1.15)
0.983
(0.861 to 1.12)
0.968
(0.846 to 1.11)
0.749
(0.655 to 0.856)
1.08
(1.00 to 1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9567 - 2 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.982
Confidence Interval (2-Sided) 90%
0.861 to 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9567 - 10 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.961
Confidence Interval 90%
0.846 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9567 - 20 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.942
Confidence Interval (2-Sided) 90%
0.829 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9567 - 40 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.861
Confidence Interval (2-Sided) 90%
0.757 to 0.979
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AZD9567 - 80 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.848
Confidence Interval (2-Sided) 90%
0.745 to 0.964
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection AZD9567 - 100 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.927
Confidence Interval (2-Sided) 90%
0.815 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection AZD9567 - 125 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.907
Confidence Interval (2-Sided) 90%
0.798 to 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection AZD9567 - 155 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.893
Confidence Interval (2-Sided) 90%
0.784 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Prednisolone - 60 mg, Pooled Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (Active Vs Placebo)
Estimated Value 0.691
Confidence Interval 90%
0.608 to 0.785
Estimation Comments [Not Specified]
Time Frame At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days after dose)
Adverse Event Reporting Description Standard adverse event collection. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product
 
Arm/Group Title AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Hide Arm/Group Description In Cohort 1, participants received single dose of AZD8567 2 mg oral suspension in the fasted state In Cohort 2, participants received single dose of AZD8567 10 mg oral suspension in the fasted state In Cohort 3, participants received single dose of AZD8567 20 mg oral suspension in the fasted state In Cohort 4, participants received single dose of AZD8567 40 mg oral suspension in the fasted state In Cohort 5, participants received single dose of AZD8567 80 mg oral suspension in the fasted state In Cohort 6, participants received single dose of AZD8567 100 mg oral suspension in the fasted state In Cohort 7, participants received single dose of AZD8567 125 mg oral suspension in the fasted state In Cohort 8, participants received single dose of AZD8567 155 mg oral suspension in the fasted state In Cohort 9, participants received orally single dose of prednisolone 60 mg capsule in the fasted state In Cohort 1-8, participants were randomized to AZD9567:placebo (6:2). In Cohort 9, participants were randomized to prednisolone:placebo (6:2)
All-Cause Mortality
AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AZD9567 - 2 mg AZD9567 - 10 mg AZD9567 - 20 mg AZD9567 - 40 mg AZD9567 - 80 mg AZD9567 - 100 mg AZD9567 - 125 mg AZD9567 - 155 mg Prednisolone - 60 mg Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/6 (0.00%)   2/6 (33.33%)   1/6 (16.67%)   0/6 (0.00%)   0/6 (0.00%)   3/18 (16.67%) 
Gastrointestinal disorders                     
Nausea * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
General disorders                     
Chest pain * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Feeling hot * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Vessel puncture site pain * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Infections and infestations                     
Nasopharyngitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Oral herpes * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Nervous system disorders                     
Dizziness * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders                     
Hyperhidrosis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/18 (5.56%) 
Vascular disorders                     
Hot flush * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 18.1.
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
Name/Title: Global Clinical Leader
Organization: AstraZeneca AB
Phone: +46 766 346712
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02512575     History of Changes
Other Study ID Numbers: D6470C00001
2015-002002-37 ( EudraCT Number )
First Submitted: July 6, 2015
First Posted: July 31, 2015
Results First Submitted: September 22, 2017
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018