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Effect of Age on the Renal Clearance of Adefovir - NCT00187746-94143(Clinical Trial 129417)



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City:  San Francisco
State:  
CA
Zip Code: 94143
Conditions: Healthy Volunteer
Purpose: Healthy African American subjects with normal hepatic and renal function will be administered 10mg adefovir dipivoxil in a fasting state. Subjects will have blood and urine collections over the following 24 hours for the measurement of adefovir renal clearance. To investigate the role of age in renal adefovir elimination, 8 subjects will be enrolled from each of the following age groups: 18-25 years and 48-55 years.
Study summary:
Criteria: Inclusion Criteria: 1. African American (either male or female); 2. Between the ages of 18 and 25 OR between the ages of 48 and 55; 3. Healthy (no self-reported ongoing medical conditions, and no clinically significant laboratory findings from a CBC and Complete Metabolic Panel); 4. Willing to participate in the study. Exclusion Criteria: 1. Subject has a medical condition that increases the risks of study participation (including pregnancy and poor renal function as defined by a calculated ClCr < 60 ml/min); 2. Any subjects with a laboratory value out of normal range and deemed to be potentially clinically significant will be excluded. Specifically, individuals with anemia (hemoglobin < 12 g/dL) or an elevation in liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, -glutamyltransferase) to higher than double the respective normal value will be excluded; 3. Subject is taking any medication other than vitamins or oral contraception; 4. Subject does not consent to participate in the study.
Study is available at: San Francisco General Hospital
San Francisco, CA 94143
United States

Primary Contact:
Chaline Brown, PharmD
Email: brownc@pharmacy.ucsf.edu
Phone: 415-476-6756

Secondary Contact:
Chaline Brown, PharmD
Email: brownc@pharmacy.ucsf.edu
Phone: 650-291-6986
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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