This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Napabucasin will be administered at dose of 240 mg twice daily, every 12 hours (BID) on days 1-2 in period 1, and on days 1-11 in period 3.
CYP450 probe drugs or BCRP transporter substrate will be administered once every period during days 1-4 in period 2, and days 6-9 in period 3.
Accel Research Sites
DeLand, Florida, United States
Pharmacokinetics for napabucasin by assessing plasma concentration
Time frame: Predose and up to 7 days post dose
Pharmacokinetics for probe drugs by assessing plasma concentration
Time frame: Predose and up to 7 days post dose
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