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Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel

NCT00697437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-12-10

No results posted yet for this study

Summary

Primary Objective:

* To confirm if ketoconazole inhibition of CYP3A activity affects fractional excretion of docetaxel in the urine.

Secondary Objective:

* To compare the metabolite ratios of the major metabolites of docetaxel in the presence and absence of CYP3A inhibition.

Conditions

Interventions

DRUG

Docetaxel

70mg q3wx 1 dose

DRUG

Ketoconazole

6 doses of oral ketoconazole 200mg bid starting 2 days before, and with 1 dose to be completed after, docetaxel infusion

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Boon Cher Goh, MBBS, MRCP · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Singapore

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697437 on ClinicalTrials.gov