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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: |
NCT01058447 |
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Date of registration:
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26/01/2010 |
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Primary sponsor: |
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Public title:
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Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
ADME |
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Scientific title:
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An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01058447 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Contacts
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Name:
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Eva S Pettersson |
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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, Sweden |
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Name:
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Tim Mant, Professor |
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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 Drug Research Unit at Guy´s Hospital, London, United Kingdom |
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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
procedure
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
Exclusion Criteria:
- Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over
the last 5 years or a cumulative total of >1 mSv per year of life
- History or presence of any clinically significant disease or disorder in the opinion
of the investigator
- Any clinically relevant abnormal findings in physical examination, clinical
chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of
the investigator
Age minimum:
50 Years
Age maximum:
65 Years
Gender:
Male
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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: AZD1981
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Primary Outcome(s)
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Pharmacokinetic variables and Radioactivity
[Time Frame: Frequent sampling occasions during study days]
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Secondary 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]
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Secondary ID(s)
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D9830C00006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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