Status:

COMPLETED

Effect of, OAT3, on the Renal Secretion of Cefotaxime

Lead Sponsor:

University of California, San Francisco

Conditions:

Focus Groups

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

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...

Detailed Description

Traditionally, clinical pharmacogenetic studies have begun with identifying a known phenotype (e.g., an aberrant response to a drug) followed by isolating the variant protein and gene responsible for ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00187655

Start Date

January 1 2004

End Date

December 1 2013

Last Update

October 29 2014

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