Status:
WITHDRAWN
Effect of Age on the Renal Clearance of Adefovir
Lead Sponsor:
University of California, San Francisco
Conditions:
Other Conditions That May Be A Focus of Clinical Attention
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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 follow...
Detailed Description
There are two major routes of elimination for drugs - hepatic metabolism and renal elimination. For small, hydrophilic molecules, the renal route predominates. The renal function of patients taking th...
Eligibility Criteria
Inclusion
- African American (either male or female);
- Between the ages of 18 and 25 OR between the ages of 48 and 55;
- Healthy (no self-reported ongoing medical conditions, and no clinically significant laboratory findings from a CBC and Complete Metabolic Panel);
- Willing to participate in the study.
Exclusion
- 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);
- 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;
- Subject is taking any medication other than vitamins or oral contraception;
- Subject does not consent to participate in the study.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00187746
Start Date
August 1 2005
End Date
April 1 2008
Last Update
November 21 2012
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94143