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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01310322

Enrollment

Registered

2011-03-08

Start date

2011-04-30

Completion date

2011-10-31

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Healthy

Keywords

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

Brief summary

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

Interventions

DRUGAZD5423

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary

Measure	Time frame	Description
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	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period	—
To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.	From screening to follow-up	To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026