Effect of Calcium Supplements on Nilotinib Hydrochloride Pharmacokinetics in Healthy Volunteers (CAMN107DUS10T) (UPCI 08-077)
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.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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®.
Jan H. Beumer, PharmD, PhD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)||Pittsburgh, Pennsylvania 15232 / 15213|