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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00979849 |
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Date of registration:
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17/09/2009 |
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Primary sponsor: |
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Public title:
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AZD8683 Single Ascending Dose Study
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Scientific title:
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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 |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00979849 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Sylvan Hurewitz |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca CPU, Philadelphia |
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Name:
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Gurdrun Schwabe |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca R&D Lund |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: AZD8683
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Drug: Placebo
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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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.]
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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.]
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Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (?z), terminal half-life (t½?z)
[Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing.]
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Secondary ID(s)
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D1883C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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