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AZD8848 Single Ascending Dose Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560234
First Posted: March 22, 2012
Last Update Posted: June 6, 2016
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.
Information provided by (Responsible Party):
AstraZeneca
March 20, 2012
March 22, 2012
July 30, 2015
June 6, 2016
June 6, 2016
May 2012
July 2014   (Final data collection date for primary outcome measure)
  • Adverse Events [ Time Frame: Screening up to Day 13 ]
    Summary of number of subjects who had at least one adverse event
  • Summary for Lymphocytes Laboratory Results [ Time Frame: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13) ]
  • Number of adverse events [ Time Frame: Screening up to Month 11 - 13 ]
  • Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs,spirometry and physical examination findings will be presented [ Time Frame: Screening up to Day 13 ]
Complete list of historical versions of study NCT01560234 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma [ Time Frame: Baseline, 24 Hours. ]
    Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
  • Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma [ Time Frame: Baseline, 48 Hours ]
    Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
  • Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum [ Time Frame: Baseline, 24 Hours. ]
    Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
  • Pharmacokinetic profile for AZD8848 and AZ12432045 combined (measured as total AZ12432045) and, if possible, for AZD8848 alone after inhaled administration of AZD8848 [ Time Frame: Day 1 and Day 2 ]
  • Pharmacodynamic effect of AZD8848 after inhaled administration by measuring CXCL10 concentration and change-from-baseline ratios in blood and induced sputum [ Time Frame: Between Day -5 and Day -2, Day 1 - Day 3 and up to Day 13 ]
Not Provided
Not Provided
 
AZD8848 Single Ascending Dose Study
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy Subjects
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD8848
    Single dose, oral inhalation (nebuliser solution)
  • Drug: Placebo
    Single dose, oral inhalation (nebuliser solution)
  • Experimental: AZD8848
    Intervention: Drug: AZD8848
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Delaney S, Biffen M, Maltby J, Bell J, Asimus S, Aggarwal A, Kraan M, Keeling D. Tolerability in man following inhalation dosing of the selective TLR7 agonist, AZD8848. BMJ Open Respir Res. 2016 Feb 23;3(1):e000113. doi: 10.1136/bmjresp-2015-000113. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
  • Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
  • Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Ability to produce sputum of good enough quality for assessment of biomarkers

Exclusion Criteria:

  • Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP > 140 mmHg, Diastolic blood pressure (DBP) > 90 mmHg, Heart rate < 40 or > 85 beats per minute)
  • Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
  • History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
  • History of asthma or allergic rhinitis
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01560234
D0542C00001
Eudract number 2011-005986-20
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Ajay Aggarwal AstraZeneca R&D, 35 Gatehouse Drive, MA 02451 USA
Principal Investigator: James Ritter, BA,MA D Phil,BM BCh,MRCP,FRCP Quintile Drug Research Unit at Guy's Hospital Quintiles Ltd 6 Newcomen Street London SE1 1YR United Kingdom
AstraZeneca
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP