A Study in Healthy Subjects 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:
NCT01635985
First received: July 5, 2012
Last updated: January 10, 2013
Last verified: January 2013

July 5, 2012
January 10, 2013
August 2012
December 2012   (final data collection date for primary outcome measure)
Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary [ Time Frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01635985 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss [ Time Frame: Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss [ Time Frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose. ] [ Designated as safety issue: No ]
  • Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss [ Time Frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose. ] [ Designated as safety issue: No ]
  • Safety profile in terms of adverse events, ECG, heart rate, blood pressure, pulse rate, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis. [ Time Frame: Screening to 28 days post dose. ] [ Designated as safety issue: Yes ]
    No formal statistical tests will be performed.
Same as current
Not Provided
Not Provided
 
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability When Administered Inhaled Via a New Dry Powder Inhaler, Turbuhaler, Spira Nebulizer and I-neb AAD System

The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects

A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bioavailability and AUC
  • Drug: AZD5423
    solution for injection, administered as intravenous infusion Corr to total dose of 250 µg 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
  • Drug: AZD5423
    dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423
  • Drug: AZD5423
    dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose 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
  • Experimental: 5
    AZD5423 inhalation Turbuhaler
    Intervention: Drug: AZD5423
  • Experimental: 6
    AZD5423, New Dry Powder Inhaler
    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
18
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
  • Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • Current smokers
  • Any clinically relevant abnormal findings
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01635985
D2340C00012, Eudract 2012-002307-17
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Carin Jorup, MD AstraZeneca R&D, Molndal Sweden
AstraZeneca
January 2013

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