Effect of Age on the Renal Clearance of Adefovir

Withdrawn before enrolling · Phase 4

Conditions studied: Other Conditions That May Be A Focus of Clinical Attention

In brief

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.

Key facts

Study ID

NCT00187746

Run by

University of California, San Francisco

People needed

0

Starts

2005-08-01

Expected to finish

2008-04-01

Last updated by the study team

2012-11-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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