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AZD5423 Single Ascending Dose Study

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ClinicalTrials.gov Identifier: NCT00963183
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):

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  (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
Primary Completion Date : November 2009
Study Completion Date : November 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.


Outcome Measures

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 ]

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov 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:
Safety
Tolerability
Healthy
Inhalation