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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014