Effect of Genetic Variation in the Transporter, OAT3, on the Renal Secretion of Cefotaxime

This study is currently recruiting participants.

Verified by University of California, San Francisco, September 2005

First Received: September 13, 2005 No Changes Posted

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187655

Purpose

In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.

Condition	Intervention
Healthy Volunteer	Drug: Cefotaxime

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Resource links provided by NLM:

Drug Information available for: Cefoxitin sodium Cefoxitin Cefotaxime

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Previous participation in the "SOPHIE" study;
Posess a specific genotype for OAT3

Exclusion Criteria:

Under 18 years old or over 45 years old;
Pregnant (pregnancy status in female subjects will be determined by a urine pregnancy test before study drug administration);
They report a prior history of any allergic reaction to cephalosporin antibiotic, or severe hypersensitivity to penicillin;
Has a prior history of renal or hepatic dysfunction (renal and hepatic function will also be determined for each subject with prescreening blood tests);
Taking a medication that could confound study results (such as known substrates or inhibitors of OATs);
They do not consent to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187655

Contacts

Contact: Chaline Brown, PharmD

415-476-6756

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:	867
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00187655 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Cefotaxime

Therapeutic Uses
Cefoxitin
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010