Effect of, OAT3, on the Renal Secretion of Cefotaxime

NCT00187655 | Completed Phase 1 Results DMC

• 1 other identifier: 867
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Focus Groups

Keywords

Healthy volunteers willing to be dosed with cefotaxime

Outcome Measures

Primary Outcomes (1)

• Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype

  Participants were stratified by their OCT3 genotype, heterozygous vs homozygous. The renal clearance of cefotaxime was measured by urine content of cefotaxime metabolites in participants after the single IV push administration of 2 grams of cefotaxime.

  post dose up to 24 hours

Study Arms (1)

Cefotaxime

OTHER

Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.

Drug: Cefotaxime

Interventions

Cefotaxime DRUG

Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.

Also known as: Claforan, Cefotaxime Sodium

Cefotaxime

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (1)

• 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. doi: 10.1152/ajprenal.00272.2005. Epub 2005 Nov 15.

  PMID: 16291576 RESULT

MeSH Terms

Interventions

Cefotaxime

Intervention Hierarchy (Ancestors)

Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Richard Castro, MD
• Organization: UCSF

Rich.Castro@ucsf.edu

4155144363

Study Officials

• Kathleen Giacomini, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: October 29, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-10