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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: |
NCT01096563 |
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Date of registration:
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25/03/2010 |
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Primary sponsor: |
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Public title:
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A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects
JSMAD |
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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 AZD9164 After Administration of Single and Multiple Ascending Doses for 13 Days in Healthy Male and Female Japanese Subjects |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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27 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01096563 |
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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, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Carin Jorup |
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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 |
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Name:
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Ulrike Lorch, MD MFPM FRCA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Richmond Pharmacology Limited |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy Japanese subjects with suitable veins for cannulation or repeated
venipuncture
- Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50
and 85 kg
- Male subjects should be willing to use barrier contraception ie, condoms with
spermicide, from the first day of dosing until 3 months after the last dose of
investigational product
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of
the Investigator, may either put the subject at risk because of participation in the
study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion
of drugs
- Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of investigational product
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: AZD9164
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Drug: Placebo
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Primary Outcome(s)
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Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
[Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study]
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Secondary Outcome(s)
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To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function
[Time Frame: Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15]
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To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity
[Time Frame: PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively)]
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Secondary ID(s)
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2009-015560-34
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D1882C00004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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