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AZD8683 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00979849
First received: September 17, 2009
Last updated: March 1, 2010
Last verified: March 2010

September 17, 2009
March 1, 2010
October 2009
January 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00979849 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
AZD8683 Single Ascending Dose Study
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • 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.
  • Drug: Placebo
    Solution for nebulisation, inhaled
  • Experimental: A
    AZD8683
    Intervention: Drug: AZD8683
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00979849
D1883C00001
Not Provided
AstraZeneca, MSD
AstraZeneca
Not Provided
Study Director: Gurdrun Schwabe AstraZeneca R&D Lund
Principal Investigator: Sylvan Hurewitz AstraZeneca CPU, Philadelphia
AstraZeneca
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP