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AZD8683 Single Ascending Dose Study

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ClinicalTrials.gov Identifier: NCT00979849
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD8683 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 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 AZD8683 After Single Ascending Doses in Healthy Male Subjects
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: A
AZD8683
 Drug: AZD8683
Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.
Placebo Comparator: B
Placebo
 Drug: Placebo
Solution for nebulisation, inhaled


Outcome Measures
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Primary Outcome Measures :
  1. Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing. ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]
  2. Pharmacokinetics: 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), apparent plasma clearance (CL/F) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]
  3. Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR). [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]
  4. Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate. [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]

Eligibility Criteria
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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 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 any prescribed or non-prescribed medication
Contacts and Locations
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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): NCT00979849


Locations
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Gurdrun Schwabe AstraZeneca R&D Lund
Principal Investigator: Sylvan Hurewitz AstraZeneca CPU, Philadelphia
More Information
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Responsible Party: AstraZeneca, MSD
ClinicalTrials.gov Identifier: NCT00979849     History of Changes
Other Study ID Numbers: D1883C00001
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by AstraZeneca:
safety
tolerability
healthy
inhalation