A Phase I, Pilot, Dose Finding Clinical Trial to Assess the Interaction Between Sunitinib and Ketoconazole to Reduce the Dose and Cost of Sunitinib for National Health System
This is a phase I, pilot, open, randomized, parallel, and cross-over trial to assess the
interaction between three different dose levels of sunitinib (50 mg, 37.5 mg, and 25 mg) and
two dose levels of ketoconazole (200 mg and 400 mg) in 12 healthy volunteers (6 voluunteers
in each group of treatment) Each volunteer will be assigned to a treatment arm (Arm A and
Arm B. Volunteers included in Arm A will take: sunitinib 50 mg, sunitinib 37.5 mg +
ketoconazole 200 mg and sunitinib 37.5 mg + 400 mg ketoconazole. Volunteers included in Arm
B will take: sunitinib 50 mg, sunitinib 25 mg + ketoconazole 200 mg and sunitinib 25 mg +
400 mg ketoconazole
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Sunitinib pharmacokinetic parameters (Maximum plasma concentration (Cmax) and Area under the plasma concentration curve (AUC0-72) obtained in the different treatment groups.
On the fourth day of each period patient will be hospitalized in the clinical trial unit in order to obtain plasma concentrations previous to the administration of the corresponding dose and at the following times port-administration: 2h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 11h, 12h, 14h, 16h, 24h, 36h, 48h amd 72h. These measures will be calculated in order to describe the pharmacokinetic profile of each treatment arm.
Up to 72 hours postdose for each period
Enrique Grande Pulido
Hospital Universitario Ramón y Cajal
Spain: Spanish Agency of Medicines