Effect of Genetic Variation in the Transporter, OAT3, on the Renal Secretion of Cefotaxime
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: Cefotaxime (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Kathleen Giacomini, PhD, Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Chaline Brown, PharmD, Phone: 415-476-6756, Email: brownc@pharmacy.ucsf.edu
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.
Clinical Details
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Previous participation in the "SOPHIE" study;
2. Posess 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.
Locations and Contacts
Chaline Brown, PharmD, Phone: 415-476-6756, Email: brownc@pharmacy.ucsf.edu
San Francisco General Hospital, San Francisco, California 94143, United States; Recruiting
Chaline Brown, PharmD, Phone: 415-476-6756, Email: brownc@pharmacy.ucsf.edu
Additional Information
Last updated: September 13, 2005
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