Effect of Age on the Renal Clearance of Adefovir

• Status: Withdrawn
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Adefovir; Adefovir dipivoxil

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.