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AZD9164 Single Ascending Dose Study in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00847249
First received: February 12, 2009
Last updated: September 22, 2009
Last verified: September 2009
History of Changes
  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
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 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: up to 48 hours post-dose. ] [ Designated as safety issue: No ]
  • Local and extrapulmonary effects [ Time Frame: up to 48 hours post-dose. ] [ Designated as safety issue: No ]

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

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

No publications provided

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
Study First Received: February 12, 2009
Last Updated: September 22, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
safety
tolerability
healthy
inhalation
Healthy males

ClinicalTrials.gov processed this record on May 21, 2013