Effect of, OAT3, on the Renal Secretion of Cefotaxime

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University of California, San Francisco. Recruitment status was Recruiting

First Received on September 13, 2005. Last Updated on March 28, 2011 History of Changes

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
Focus Groups	Drug: Cefotaxime

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Effect of Genetic Variation in the Transporter, OAT3, on the Renal Secretion of Cefotaxime

Resource links provided by NLM:

Drug Information available for: Cefoxitin sodium Cefoxitin Cefotaxime

U.S. FDA Resources

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

Primary Outcome Measures:

Examine the contribution of OAT3 and related variants [ Time Frame: Cefotaxime ] [ Designated as safety issue: No ]
examine the contribution of OAT3 and related variants to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variants of OAT3 and related variants.

Estimated Enrollment:	28
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cefotaxime Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.	Drug: Cefotaxime Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes. Other Names: Claforan Cefotaxime Sodium

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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: Ricahrd Castro, MD	415-476-1840	castror@pharmacy.ucsf.edu
Contact: Sook Wah Yee, Ph.D	415-514-4363	SookWah.Yee@ucsf.edu

Locations

United States, California
San Francisco General Hospital CTSI CRC	Recruiting
San Francisco, California, United States, 94143
Contact: Hector Vizoso, RN-BC, MSN 415-206-3317 hvizoso@sfghgcrc.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Kathleen Giacomini, PhD

University of California, San Francisco

More Information

Publications:

Erdman AR, Mangravite LM, Urban TJ, Lagpacan LL, Castro RA, de la Cruz M, Chan W, Huang CC, Johns SJ, Kawamoto M, Stryke D, Taylor TR, Carlson EJ, Ferrin TE, Brett CM, Burchard EG, Giacomini KM. The human organic anion transporter 3 (OAT3; SLC22A8): genetic variation and functional genomics. Am J Physiol Renal Physiol. 2006 Apr;290(4):F905-12. Epub 2005 Nov 15.

Responsible Party:	Kathleen Giacomini, Ph.D, UCSF
ClinicalTrials.gov Identifier:	NCT00187655 History of Changes
Other Study ID Numbers:	867
Study First Received:	September 13, 2005
Last Updated:	March 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Healthy volunteers willing to be dosed with cefotaxime

Additional relevant MeSH terms:

Cefotaxime
Cefoxitin
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012