AZD8848 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01560234
First received: March 20, 2012
Last updated: May 5, 2016
Last verified: April 2016
Results First Received: July 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: AZD8848
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 47 male and female subjects (6 cohorts with additional 2 cohorts) were randomized in the study.There were 6 subjects per cohort (4 subjects received AZD8848 and 2 subjects received placebo), with the exception of Cohort 3 (1.5 μg), where 3 subjects received AZD8848 and 2 subjects received placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Commercial 0.9% sodium chloride solution.
Cohort 1 AZD8848 0.15 μg
Cohort 2 AZD8848 0.5 ug
Cohort 3 AZD8848 1.5 μg
Cohort 4 AZD8848 5 μg
Cohort 5 AZD8848 15 μg
Cohort 7 AZD8848 15 μg (Multiple Inhalation)
Cohort 6 and 8 AZD8848 30 μg (similar investigational product administration conditions)

Participant Flow:   Overall Study
    Placebo     Cohort 1     Cohort 2     Cohort 3     Cohort 4     Cohort 5     Cohort 7     Cohort 6 and 8  
STARTED     16     4     4     3     4     4     4     8  
COMPLETED     13     4     3     3     4     2     4     6  
NOT COMPLETED     3     0     1     0     0     2     0     2  
Lost to Follow-up                 3                 0                 1                 0                 0                 2                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All available data were used for the baseline analysis

Reporting Groups
  Description
Placebo Commercial 0.9% sodium chloride solution.
Cohort 1 AZD8848 0.15 μg
Cohort 2 AZD8848 0.5 ug
Cohort 3 AZD8848 1.5 μg
Cohort 4 AZD8848 5 μg
Cohort 5 AZD8848 15 μg
Cohort 7 AZD8848 15 μg (Multiple Inhalation)
Cohort 6 and 8 AZD8848 30 μg (similar investigational product administration conditions)
Total Total of all reporting groups

Baseline Measures
    Placebo     Cohort 1     Cohort 2     Cohort 3     Cohort 4     Cohort 5     Cohort 7     Cohort 6 and 8     Total  
Number of Participants  
[units: participants]
  16     4     4     3     4     4     4     8     47  
Age  
[units: Years]
Mean (Standard Deviation)
  27  (6)     29  (10)     23  (3)     24  (5)     31  (4)     27  (6)     30  (9)     31  (9)     28  (7)  
Gender  
[units: participants]
                 
Female     8     1     2     2     4     2     3     1     23  
Male     8     3     2     1     0     2     1     7     24  
Subject characteristics (Height)  
[units: cm]
Mean (Standard Deviation)
  170.1  (7.1)     168.6  (1.7)     170.5  (8.5)     167.7  (15.5)     166.0  (5.0)     175.0  (8.3)     169.3  (11.1)     176.9  (8.6)     170.9  (8.3)  
Subject characteristics (Weight)  
[units: kg]
Mean (Standard Deviation)
  72.1  (11.2)     76.9  (6.7)     68.2  (12.2)     71.4  (5.0)     67.7  (14.2)     78.1  (16.3)     69.4  (10.5)     79.3  (8.0)     73.3  (10.9)  
Subject characteristics (BMI)  
[units: kg/m²]
Mean (Standard Deviation)
  24.81  (2.71)     27.02  (1.94)     23.41  (3.50)     25.63  (3.16)     24.48  (4.46)     25.31  (3.47)     24.41  (4.87)     25.40  (2.37)     25.01  (3.00)  



  Outcome Measures
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1.  Primary:   Adverse Events   [ Time Frame: Screening up to Day 13 ]

2.  Primary:   Summary for Lymphocytes Laboratory Results   [ Time Frame: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13) ]

3.  Secondary:   Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)   [ Time Frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h ]

4.  Secondary:   Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)   [ Time Frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h ]

5.  Secondary:   Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)   [ Time Frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h ]

6.  Secondary:   Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma   [ Time Frame: Baseline, 24 Hours. ]

7.  Secondary:   Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma   [ Time Frame: Baseline, 48 Hours ]

8.  Secondary:   Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum   [ Time Frame: Baseline, 24 Hours. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ajay Aggarwal
Organization: AstraZeneca R&D
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01560234     History of Changes
Other Study ID Numbers: D0542C00001
Eudract number 2011-005986-20
Study First Received: March 20, 2012
Results First Received: July 30, 2015
Last Updated: May 5, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency