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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: |
NCT00970775 |
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Date of registration:
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01/09/2009 |
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Primary sponsor: |
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Public title:
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AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects
JSAD |
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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 Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00970775 |
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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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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 male and non-fertile female subjects aged =20 to =55 years with
suitable veins for cannulation or repeated venepuncture.
- Body weight 45-90 kg and Body mass index (BMI) =18.0 and =27.0 kg/m2
- Clinically normal physical findings including supine blood pressure, pulse rate,
orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as
judged by the Investigator.
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.
- Any clinically significant illness/infection or medical/surgical procedure or trauma,
as judged by the Principal Investigator, within 3 months of the first administration
of investigational product.
- Frequent use of tobacco or other nicotine containing products. Frequent use is
defined as smoking or consumption/intake of nicotine products more than two days per
week during the last 12 weeks.
Age minimum:
20 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Intervention(s)
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Drug: AZD2423
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Drug: Placebo
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Primary Outcome(s)
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To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
[Time Frame: From screening period to follow-up visit, 40 days (Maximum).]
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Secondary Outcome(s)
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Exploratory endpoints;Levels of CCL2 pre-and post dose
[Time Frame: Blood sampling after dosing, 3 days]
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To characterize the pharmacokinetics of AZD2423 in plasma and urine.
[Time Frame: Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)]
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Secondary ID(s)
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D2600C00003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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