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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Bioavailability and AUC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD5423 iv

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

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

2

AZD5423 inhalation, Spira

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

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

3

AZD5423 inhalation I-neb

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

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

4

AZD5423 oral

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

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

5

AZD5423 inhalation Turbuhaler

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423

6

AZD5423, New Dry Powder Inhaler

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423

Interventions

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AZD5423

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

Intervention Type DRUG

AZD5423

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

Intervention Type DRUG

AZD5423

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

Intervention Type DRUG

AZD5423

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

Intervention Type DRUG

AZD5423

dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423

Intervention Type DRUG

AZD5423

dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423

Intervention Type DRUG

Eligibility Criteria

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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