AZD5423 Single Ascending Dose Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963183
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):

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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Pharmacodynamics - Plasma cortisol concentrations [ Time Frame: Frequent sampling occasions during study days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963183

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

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00963183     History of Changes
Other Study ID Numbers: D2340C00001
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: November 2014

Keywords provided by AstraZeneca: