AZD5423 Single Ascending Dose Study

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00963183

First received: August 17, 2009

Last updated: December 1, 2009

Last verified: December 2009

History of Changes

Purpose

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	Intervention	Phase
Healthy Volunteers	Drug: AZD5423 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

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) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]
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). [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]
Pharmacodynamics - Plasma cortisol concentrations [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	August 2009
Study Completion Date:	November 2009

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963183

Locations

United Kingdom
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

More Information

No publications provided

Responsible Party:	Carin Jorup, MD, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00963183 History of Changes
Other Study ID Numbers:	D2340C00001
Study First Received:	August 17, 2009
Last Updated:	December 1, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Safety
Tolerability
Healthy
Inhalation

ClinicalTrials.gov processed this record on May 16, 2013

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