Trial Outcomes & Findings for Effect of, OAT3, on the Renal Secretion of Cefotaxime (NCT NCT00187655)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

post dose up to 24 hours

Results posted on

2014-10-29

Participant Flow

Enrollment concluded with 24 subjects and study is in analysis phase. Recruitment of subjects were At the CRC at SFGH. Dates of recruitment 2004-9/2011.

No wash-out as these were healthy control subjects not currently on any medications.

Participant milestones

Participant milestones
Measure	Cefotaxime Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of, OAT3, on the Renal Secretion of Cefotaxime

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cefotaxime n=24 Participants Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.5 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: post dose up to 24 hours

Population: The OAT3 Ile305Phe variant was determined to be heterozygous or homozygous for each healthy participant.

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.

Outcome measures

Outcome measures
Measure	Heterozygous for the Ile305Phe Variant n=12 Participants 2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as heterozygous for the Ile305Phe variant and compared to volunteers that were homozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.	Homozygous for OAT3-Ile305Phe Variant n=12 Participants 2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as homozygous for the Ile305Phe variant and compared to volunteers that were heterozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype	84.8 mL/min Standard Deviation 32.1	158 mL/min Standard Deviation 44.1

Adverse Events

Cefotaxime

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Castro, MD

UCSF

Phone: 4155144363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place