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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014