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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
History of Changes
  Purpose

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


Condition Intervention Phase
Bioavailability and AUC
 Drug: AZD5423
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD5423 iv
 Drug: AZD5423
solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423
Experimental: 2
AZD5423 inhalation, Spira
 Drug: AZD5423
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
Experimental: 3
AZD5423 inhalation I-neb
 Drug: AZD5423
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
Experimental: 4
AZD5423 oral
 Drug: AZD5423
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
Experimental: 5
AZD5423 inhalation Turbuhaler
 Drug: AZD5423
dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423
Experimental: 6
AZD5423, New Dry Powder Inhaler
 Drug: AZD5423
dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635985

Locations
United Kingdom
London, UK, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carin Jorup, MD AstraZeneca R&D, Molndal Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01635985     History of Changes
Other Study ID Numbers: D2340C00012, Eudract 2012-002307-17
Study First Received: July 5, 2012
Last Updated: January 10, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I, Healthy male volunteers, pharmacokinetics

ClinicalTrials.gov processed this record on May 22, 2013