This research study is being conducted through the University of Pittsburgh Cancer Institute (UPCI). It will evaluate the concentrations of Tasigna®, an oral drug used to treat some types of cancer, in the blood of healthy volunteers when taken with and without Tums Ultra®, a calcium product often used in the treatment of upset stomach and as a calcium supplement.
This is an open-label, single-institution, randomized cross-over, fixed-schedule investigation of the effects of calcium carbonate on the pharmacokinetics (PK) of Tasigna® in healthy volunteers. Healthy volunteers will be recruited to participate in this study such that twelve subjects (6 men / 6 women) will complete the study at UPCI. Subjects will be compensated for participation. Half of the subjects will receive Tasigna® alone on Day 1 and Tasigna® and calcium carbonate on Day 15, and the other half will receive Tasigna® and calcium carbonate on Day 1 and Tasigna® alone on Day 15, determined by randomization of subjects receiving either the combination or Tasigna® alone during the first visit. Doses will be 400 mg Tasigna® (2 x 200 mg tablets) and 4000 mg calcium carbonate (4 x Tums Ultra 1000® chewable tablets, equivalent to 4000 mg calcium carbonate or 1600 mg calcium). Multiple PK blood samples will be taken from Days 1-4 and Days 15-18. Tasigna® PK will be assessed after oral administration of 400 mg Tasigna® alone, and after oral administration of 400 mg Tasigna® with concomitant administration of 4000 mg calcium carbonate. Two two-day/one-night inpatient stays and four brief outpatient visits are required to accommodate all study procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
14
Dosage form: capsules Dosage: 400 mg (2 x 200 mg capsule) Frequency \& duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
Dosage form: tablets Dosage: 4000 mg (4 x 1000 mg tablet) Frequency: On an 18-day schedule, once daily day 15 (for Arm 1); or once daily day 1 (for Arm 2)
University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)
Pittsburgh, Pennsylvania, United States
To define the effect of administration of a calcium salt (calcium carbonate) on the PK (in particular the area under the nilotinib plasma concentration versus time curve) of nilotinib (Tasigna® ) in healthy volunteers.
Time frame: PK blood samples are drawn from each subject at time 0 (before each dose of Tasigna®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hrs after adminstration of Tasigna®.
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