A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD5423 After Single Ascending Doses in Healthy Male Subjects

AstraZeneca1 site in 1 country72 target enrollmentAugust 2009

ConditionsHealthy Volunteers

InterventionsAZD5423 Placebo

DrugsAZD5423 Placebo

Overview

Phase: Phase 1
Intervention: AZD5423
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 72
Locations: 1
Primary Endpoint: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

November 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed, written and dated informed consent prior to any study specific procedures
•Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

•Any clinically significant disease or disorder
•Any clinically significant abnormalities at screening examination
•Use of any prescribed or non-prescribed medication

Arms & Interventions

A

Drug: AZD5423

Intervention: AZD5423

B

Drug: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination

Time Frame: Frequent sampling occasions during study days

Secondary Outcomes

Pharmacokinetics - Maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)] and from zero to infinity (AUC)(Frequent sampling occasions during study days)
Add'l pharmacokinetics - Terminal rate constant (λz); terminal half-life (t½λz), Apparent plasma clearance (CL/F), apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT).(Frequent sampling occasions during study days)
Pharmacodynamics - Plasma cortisol concentrations(Frequent sampling occasions during study days)