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Effect of, OAT3, on the Renal Secretion of Cefotaxime

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187655
First received: September 13, 2005
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group 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:

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: December 2013
Primary Completion Date: December 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

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Previous participation in the "SOPHIE" study;
  2. Possess a specific genotype for OAT3

Exclusion Criteria:

  1. Under 18 years old or over 45 years old;
  2. Pregnant (pregnancy status in female subjects will be determined by a urine pregnancy test before study drug administration);
  3. They report a prior history of any allergic reaction to cephalosporin antibiotic, or severe hypersensitivity to penicillin;
  4. Has a prior history of renal or hepatic dysfunction (renal and hepatic function will also be determined for each subject with prescreening blood tests);
  5. Taking a medication that could confound study results (such as known substrates or inhibitors of OATs);
  6. They do not consent to participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187655

Locations
United States, California
San Francisco General Hospital CTSI CRC
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187655     History of Changes
Other Study ID Numbers: 867
Study First Received: September 13, 2005
Last Updated: September 10, 2012
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 June 18, 2013