Effect of Age on the Renal Clearance of Adefovir

NCT00187746 | Withdrawn Phase 4 DMC

• 1 other identifier: 992
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Keywords

Healthy Control

Outcome Measures

Primary Outcomes (1)

• Renal Clearance of adefovir

  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.

  24 hours

Study Arms (2)

Age 18-25 years

EXPERIMENTAL

African American subjects between the ages 18 to 25 years given Adefovir dipivoxil.

Drug: Adefovir dipivoxil

Age 48-55 years

EXPERIMENTAL

African American subject between the ages 48 to 55 years given Adefovir dipivoxil.

Drug: Adefovir dipivoxil

Interventions

Adefovir dipivoxil DRUG

Subjects will be given a single oral dose of 10 mg of adefovir dipivoxil

Also known as: HEPSERA® is the tradename

Age 18-25 years; Age 48-55 years

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Fujita T, Brown C, Carlson EJ, Taylor T, de la Cruz M, Johns SJ, Stryke D, Kawamoto M, Fujita K, Castro R, Chen CW, Lin ET, Brett CM, Burchard EG, Ferrin TE, Huang CC, Leabman MK, Giacomini KM. Functional analysis of polymorphisms in the organic anion transporter, SLC22A6 (OAT1). Pharmacogenet Genomics. 2005 Apr;15(4):201-9. doi: 10.1097/01213011-200504000-00003.

  PMID: 15864112 BACKGROUND

MeSH Terms

Interventions

adefovir dipivoxil

Study Officials

• Kathleen Giacomini, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

US (1)