Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Oral KIT/PDGFRA kinase inhibitor
Oral antihyperglycemic agent
Mayo Clinic Florida
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Oregon Health & Science University
Portland, Oregon, United States
Maximum Observed Plasma Concentration for Repaglinide
Measure the Cmax
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide
Measure the AUC0-t
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
AUC from time 0 and extrapolated to infinity (AUC0-∞)
Measure the AUC0-∞
Time frame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Incidence of Adverse Events
Adverse events \[TEAEs, SAEs\], dose reduction, dose interruption, or discontinuation, vital signs (heart rate \[beats/min\], and changes in laboratory parameters (chemistry, hematology, urinalysis, coagulation).
Time frame: Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.