This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect of food on the bioavailability of AXL1717 including patients with advanced malignant tumors
This is a randomized, crossover, open label, phase I study to assess the effect of food on the bioavailability of AXL1717 in advanced cancer patients. A single, oral dose of AXL1717 is to be administered to patients on each of two occasions that are 7-day apart, in random order: after an overnight fast (fasted treatment) and with a high-fat or moderate-fat breakfast (fed treatment).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
13
KFUE
Uppsala, Sweden
Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient
Time frame: several samples within 24 hours
Safety of AXL1717 through adverse event reporting
Time frame: Up to 30 days after last dose of study drug
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