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

Primary Purpose

Healthy, Asthma

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD5423

About this trial

This is an interventional basic science trial for Healthy focused on measuring Phase I, Healthy male volunteers, mild asthmatics, pharmacokinetics, Bioavailability and AUC, Level of AZD5423 in your blood

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

AZD5423 iv

AZD5423 inhalation, Spira

AZD5423 inhalation I-neb

AZD5423 oral

Outcomes

Primary Outcome Measures

Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)

Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)

Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)

Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).

Secondary Outcome Measures

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

To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.

To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)

Full Information

NCT ID

NCT01310322

First Posted

February 17, 2011

Last Updated

January 13, 2015

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01310322

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Asthma

Keywords

Phase I, Healthy male volunteers, mild asthmatics, pharmacokinetics, Bioavailability and AUC, Level of AZD5423 in your blood

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD5423 iv

Arm Title

Arm Type

Experimental

Arm Description

AZD5423 inhalation, Spira

Arm Title

Arm Type

Experimental

Arm Description

AZD5423 inhalation I-neb

Arm Title

Arm Type

Experimental

Arm Description

AZD5423 oral

Intervention Type

Drug

Intervention Name(s)

AZD5423

Intervention Description

solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423

Intervention Type

Drug

Intervention Name(s)

AZD5423

Intervention Description

nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423

Intervention Type

Drug

Intervention Name(s)

AZD5423

Intervention Description

nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423

Intervention Type

Drug

Intervention Name(s)

AZD5423

Intervention Description

nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423

Primary Outcome Measure Information:

Title

Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)

Time Frame