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Effect of Calcium Supplements on Nilotinib Hydrochloride Pharmacokinetics in Healthy Volunteers (CAMN107DUS10T) (UPCI 08-077)

18 Years
Open (Enrolling)

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Trial Information

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.

Inclusion Criteria:

- Healthy men or women 18 years of age or older. Healthy subjects are defined as
individuals who are free from clinically significant illness or disease (such as
coronary arterial disease, chronic heart failure, bleeding disorder, hypertension,
chronic renal failure etc.) as determined by their medical history, physical
examination, and laboratory studies.

- Body Mass Index (BMI) < 31 kg/m2 (weight/height2).

- Female patients of childbearing potential must have negative pregnancy test within 14
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Male and
female patients of reproductive potential must agree to employ an effective barrier
method of birth control throughout the study and for up to 3 months following
discontinuation of study drug.

- Written, voluntary informed consent.

Exclusion Criteria:

- Abnormal marrow function as defined by leucocyte, neutrophil, or platelet counts
outside of normal limits.

- Any evidence of renal dysfunction (proteinuria; serum creatinine > upper limit of
normal; or if serum creatinine > upper limit of normal, a calculated creatinine
clearance < 60 mL/min/1.73 m2).

- Impaired hepatic function (liver enzymes greater than the upper limit of normal or
bilirubin outside the normal range).

- QTcF > 450 msec on screening ECG (using the QTcF formula).

- Patient with electrolyte abnormality (e.g., hypokalemia, hypomagnesemia,
hypophosphatemia, hyperkalemia, hypocalcemia, hyponatremia).

- Taking any medications (including over the counter products), herbal products,
mineral supplements or vitamins (other than a daily multivitamin preparation), other
than contraceptives (for women), within 2 weeks of start of the study. All forms of
contraceptive medication are permissible for this study and would not result in a
female's exclusion from participation. Patients who take medications on a chronic
basis, such as antihypertensive medications or thyroid replacement therapy, etc. are
not eligible for the study.

- Subjects has received any other investigational agents within 28 days of first day of
study drug dosing.

- Female subjects who are pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome 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®.

Safety Issue:


Principal Investigator

Jan H. Beumer, PharmD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

August 2013

Related Keywords:

  • Healthy
  • Pharmacokinetics
  • Healthy volunteers
  • No condition
  • Pharmacokinetics study



University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)Pittsburgh, Pennsylvania  15232 / 15213