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AZD9164 Single Ascending Dose Study in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847249
First Posted: February 19, 2009
Last Update Posted: September 23, 2009
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.
Information provided by:
AstraZeneca
  Purpose
The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Condition Intervention Phase
Healthy Drug: AZD9164 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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 AZD9164 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) [ Time Frame: up to 48 hours post-dose. ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: up to 48 hours post-dose. ]
  • Local and extrapulmonary effects [ Time Frame: up to 48 hours post-dose. ]

Enrollment: 65
Study Start Date: February 2009
Study Completion Date: April 2009
Arms Assigned Interventions
Experimental: 1
Solution for nebulisation, inhaled
Drug: AZD9164
Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
Placebo Comparator: 2
Solution for nebulisation, inhaled
Drug: Placebo
Each subject will receive a single-dose.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening examinations
  • 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): NCT00847249


Locations
Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Anders Luts AstraZeneca
Principal Investigator: Ulf Malmqvist Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden
  More Information

Responsible Party: Anders Luts, Medical Science Director, Emerging Project, Team 3, AstraZeneca
ClinicalTrials.gov Identifier: NCT00847249     History of Changes
Other Study ID Numbers: D1882C00001
EudraCT No.2008-007188-18
First Submitted: February 12, 2009
First Posted: February 19, 2009
Last Update Posted: September 23, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
safety
tolerability
healthy
inhalation
Healthy males


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