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A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01310322
First received: February 17, 2011
Last updated: October 26, 2011
Last verified: October 2011
History of Changes

February 17, 2011
October 26, 2011
April 2011
October 2011   (final data collection date for primary outcome measure)
  • Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F) [ Time Frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary) [ Time Frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral) [ Time Frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC). [ Time Frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01310322 on ClinicalTrials.gov Archive Site
  • To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax [ Time Frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry. [ Time Frame: From screening to follow-up ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)
Same as current
Not Provided
Not Provided
 
A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients With Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 When Administered Intravenously, Orally, Inhaled Via SPIRA Nebuliser or Inhaled Via I-neb® AAD Systems

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy
  • Asthma
  • Drug: AZD5423
    solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
  • Drug: AZD5423
    nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
  • Drug: AZD5423
    nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
  • Drug: AZD5423
    nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
  • Experimental: 1
    AZD5423 iv
    Intervention: Drug: AZD5423
  • Experimental: 2
    AZD5423 inhalation, Spira
    Intervention: Drug: AZD5423
  • Experimental: 3
    AZD5423 inhalation I-neb
    Intervention: Drug: AZD5423
  • Experimental: 4
    AZD5423 oral
    Intervention: Drug: AZD5423
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
  • Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
  • Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • Any clinically relevant abnormal findings
  • Current smokers
  • Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
  • Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01310322
D2340C00008
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Darren Wilbraham, Dr Quintiles Drug Research Unit at Guy's Hospital
AstraZeneca
October 2011

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