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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: |
NCT01359605 |
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Date of registration:
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19/05/2011 |
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Primary sponsor: |
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Public title:
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Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
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Scientific title:
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An Open-Label, Single-Dose, Study to Assess the Metabolism and Elimination of Varespladib After Oral Administration of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01359605 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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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
- Healthy males, 19 to 55 years of age
- Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive
Exclusion Criteria:
- 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, or vital signs at baseline in the opinion of the
investigator
Age minimum:
19 Years
Age maximum:
55 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: varespladib methyl
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Primary Outcome(s)
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Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples
[Time Frame: 1 hour prior to drug, and post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, and 120 hours after drug]
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Secondary ID(s)
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AN-CVD2215
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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