This is an open-label study in advanced solid tumor patients to determine if entrectinib affects the pharmacokinetics of midazolam and any of its pharmacologically active metabolites.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
600 mg oral capsule (fasted and fed)
2 mg oral syrup (fasted)
SCRI-Denver Drug Development Program
Denver, Colorado, United States
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States
Tennessee Oncology
Nashville, Tennessee, United States
AUClast
Area under the concentration-time curve from 0 to the last measurable concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
Time frame: 4 weeks
AUCinf
Area under the concentration-time curve from 0 to infinity of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
Time frame: 4 weeks
Cmax
Peak plasma concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
Time frame: 4 weeks
Tmax
Time of maximum concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
Time frame: 4 weeks
t1/2
Terminal half-life of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.
Time frame: 4 weeks
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