Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers

NCT00732888 | Completed Phase 1 DMC

• 3 other identifiers: 08-077CAMN107DUS10TUPCI 08-077
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Healthy

Keywords

Pharmacokinetics; Healthy volunteers; No condition; Pharmacokinetics study

Outcome Measures

Primary Outcomes (1)

• 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®.

Study Arms (2)

1

OTHER

On an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 15; and Tasigna® once daily on days 1 and 15 (i.e., Tasigna® alone on day 1, and combination of Tasigna® and calcium supplement on day 15).

Drug: Nilotinib Hydrochloride; Dietary Supplement: calcium carbonate

2

OTHER

On an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 1; and Tasigna® once daily on days 1 and 15 (i.e., combination of Tasigna® and calcium supplement on day 1, Tasigna® alone on day 15).

Drug: Nilotinib Hydrochloride; Dietary Supplement: calcium carbonate

Interventions

Nilotinib Hydrochloride DRUG

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)

Also known as: Tasigna®, AMN107

1; 2

calcium carbonate DIETARY_SUPPLEMENT

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)

Also known as: Tums Ultra 1000®

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Jan Beumer: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

nilotinib; Calcium Carbonate

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Jan H. Beumer, PharmD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 12, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

US (1)