AZD8848 Single Ascending Dose Study

This study is currently recruiting participants.
Verified February 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01560234
First received: March 20, 2012
Last updated: February 18, 2014
Last verified: February 2014

March 20, 2012
February 18, 2014
April 2012
May 2014   (final data collection date for primary outcome measure)
  • Number of adverse events [ Time Frame: Screening up to Month 11 - 13 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01560234 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile for AZD8848 and AZ12432045 combined (measured as total AZ12432045) and, if possible, for AZD8848 alone after inhaled administration of AZD8848. Parameters include AUC, Cmax, tmax, lamda z, t1/2lamda z, AUC (0-t), CL/F and Vz/F [ Time Frame: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h ] [ Designated as safety issue: No ]
  • 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, at 3 timepoints on Day 1 - Day 3 and on Day 13 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
April 2015
May 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
Both
18 Years to 45 Years
Yes
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
Contact: Quintiles Drug Research Unit Call Centre 0800 634 1132
United Kingdom
 
NCT01560234
D0542C00001, Eudract number 2011-005986-20
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Aray Aggarwal AstraZeneca R&D, 35 Gathouse 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
February 2014

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