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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: |
NCT01150812 |
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Date of registration:
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21/06/2010 |
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Primary sponsor: |
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Public title:
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Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
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Scientific title:
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A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01150812 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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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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Peter Held |
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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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Ralph Schutz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Quintiles |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor
more than 100 kg
Exclusion Criteria:
- History of any clinically significancy disease or disorder which, in the opinion of
the Investigator, may either put the volunteer at risk because of participation in
the study, or influence the results or the volunteer'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
- Personal or family history of bleeding disorders, or reasonable suspicion of vascular
malformations, including aneurysms.
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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Thrombin Inhibition
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Intervention(s)
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Drug: AZD8165
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Primary Outcome(s)
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Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)
[Time Frame: Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.]
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Secondary Outcome(s)
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Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time
[Time Frame: Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT)]
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Plasma and urine levels of AZD8165 and its active metabolite AZ12971554
[Time Frame: Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554]
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Secondary ID(s)
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D2890C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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