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
18 Years
35 Years
Male
Cancer
Trial Information
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
Inclusion Criteria:
- Healthy individuals men who give their written consent to participate in the study,
after having received information about the design, the project objectives, the risks
and that at any moment they can refuse their cooperation.
- Age between 18 and 35 years.
- Subjects with a BMI that is between 19 and 28.
- Healthy subjects, without any organic or psychological pathology.
- Clinical history and physical examination within normal limits.
- Lack of clinically relevant abnormalities in blood test (hematology, biochemistry,
virology) and urine test
- Vital signs and electrocardiographic recording in the normal range.
Exclusion Criteria:
- Subjects suffering from organic or psychological pathology. Prior to the inclusion of
any volunteer it should be considered all security parameters mentioned in the
protocol (biochemical markers of kidney damage and / or liver out of the normal range
set by the laboratory).
- Subjects who have received prescription drug treatment in the last 15 days or any
medication within 48 hours before receiving study medication.
- Known hypersensitivity to any drug
- Suspected of drug abuse
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Sunitinib pharmacokinetic parameters (Maximum plasma concentration (Cmax) and Area under the plasma concentration curve (AUC0-72) obtained in the different treatment groups.
Outcome Description:
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.
Outcome Time Frame:
Up to 72 hours postdose for each period
Safety Issue:
No
Principal Investigator
Enrique Grande Pulido
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Universitario Ramón y Cajal
Authority:
Spain: Spanish Agency of Medicines
Study ID:
KS-ONCOFARMA-01
NCT ID:
NCT01548170
Start Date:
April 2011
Completion Date:
July 2011
Related Keywords:
- Cancer
- Pharmacokinetic
- Sunitinib
- Ketoconazol
- interaction, Phase I
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