drugset / Trial / NCT01743300

The Influence of Phenotype, Grapefruit Juice and Orange Juice on the Pharmacokinetics of Sunitinib in Cancer Patients

NCT01743300

Phase 1 Completed 15 enrolled Leiden University Medical Center
Non-randomizedSingle-groupOpen-label

Summary

In this prospective pharmacokinetic we investigate the following topics: * The influence of grapefruit juice and orange juice on the steady-state pharmacokinetics of sunitinib in cancer patients * The influence of sunitinib on the pharmacokinetics of midazolam in cancer patients * The relationship between Cytochrome-P450-3A4 (CYP3A4) phenotype, as assessed using the midazolam clearance test, and the steady-state pharmacokinetics of sunitinib in cancer patients * The effect of grapefruit juice and orange juice on CYP3A4 metabolism

Timeline

Start
2007-07
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 7.5 mg Oral
Comparator Sunitinib Small molecule 50 mg Oral

Indications

No indication recorded.