AZD5423 Single Ascending Dose Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00963183

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

23.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: AZD5423 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Drug: AZD5423	Drug: AZD5423 Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
Placebo Comparator: B Drug: Placebo	Drug: Placebo Solution for nebulisation, inhaled. Each subject will receive a single-dose.

Arm

Intervention/Treatment

Experimental: A

Drug: AZD5423

Drug: AZD5423

Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

Placebo Comparator: B

Drug: Placebo

Drug: Placebo

Solution for nebulisation, inhaled. Each subject will receive a single-dose.

Outcome Measures

Primary Outcome Measures

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination [Frequent sampling occasions during study days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	London		United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Jorup Carin, AstraZeneca R&D, Lund, Sweden
Principal Investigator: Darren Wilbraham, Guy's Drug Research Unit, Quintiles Ltd, London, UK