Phase 1
Completed N=24
Effect of, OAT3, on the Renal Secretion of Cefotaxime
Focus Groups
Source: ClinicalTrials.gov NCT00187655 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype — 84.8; 158 mL/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype |
84.8; 158 | — |
Eligibility Criteria
Inclusion Criteria
- Previous participation in the "SOPHIE" study;
- Has 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.
Data sourced from ClinicalTrials.gov (NCT00187655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.