This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.
This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. On Day 1 of Period 1 (Treatment A), a single oral dose of neratinib will be administered followed by PK sampling for 72 hours. In Period 2 (Treatment B), multiple oral doses of lansoprazole will be administered once daily for 7 consecutive days with a single oral dose of neratinib administered on Day 5. PK sampling for neratinib will be taken for 72 hours following neratinib dosing on Day 5. The washout period will be at least 14 days between each neratinib dose.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
15
Celerion
Tempe, Arizona, United States
AUC(0-t) of neratinib with and without lansoprazole
The area under the plasma concentration-time curve, from time 0 to the last measurable nonzero concentration, as calculated by the linear trapezoidal method.
Time frame: 0, 0.5, 1, 2, 2.75, 3.5, 4.25, 5, 5.75, 6.5, 7.25, 8, 10, 12, 24, 32, 48, 60, and 72 hours post-dose
AUC(0-inf) of neratinib with and without lansoprazole
The area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC(0-inf) is calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Time frame: 0, 0.5, 1, 2, 2.75, 3.5, 4.25, 5, 5.75, 6.5, 7.25, 8, 10, 12, 24, 32, 48, 60, and 72 hours post-dose
Cmax of neratinib with and without lansoprazole
Maximum observed concentration.
Time frame: 0, 0.5, 1, 2, 2.75, 3.5, 4.25, 5, 5.75, 6.5, 7.25, 8, 10, 12, 24, 32, 48, 60, and 72 hours post-dose
Number of participants with adverse events
Safety endpoints will include all AEs, physical examinations, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory tests (hematology, serum chemistry, and urinalysis).
Time frame: over 4 week study period
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