Effect of Age on the Renal Clearance of Adefovir

This study is currently recruiting participants.

Verified by University of California, San Francisco, September 2005

First Received: September 14, 2005 No Changes Posted

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187746

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.

Condition	Intervention
Healthy Volunteer	Drug: Adefovir dipivoxil

Drug Information available for: Adefovir Adefovir dipivoxil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:	Effect of Age on the Renal Clearance of Adefovir

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Renal Clearance of adefovir

Estimated Enrollment:	16
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187746

Contacts

Contact: Chaline Brown, PharmD

650-291-6986

brownc@pharmacy.ucsf.edu

Locations

United States, California
San Francisco General Hospital	Recruiting
San Francisco, California, United States, 94143
Contact: Chaline Brown, PharmD 415-476-6756 brownc@pharmacy.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Kathleen Giacomini, PhD

University of California, San Francisco

More Information

No publications provided

Study ID Numbers:	992
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00187746 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Retroviral Agents
Adefovir dipivoxil
Healthy

Antiviral Agents
Adefovir
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Adefovir dipivoxil

Antiviral Agents
Adefovir
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009