Status:
COMPLETED
Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers
Lead Sponsor:
Jan Beumer
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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, i...
Detailed Description
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. Healt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00732888
Start Date
November 1 2008
End Date
September 1 2011
Last Update
December 18 2013
Active Locations (1)
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1
University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)
Pittsburgh, Pennsylvania, United States, 15232