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Sponsors and Collaborators: |
University of Pittsburgh Novartis Pharmaceuticals |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00732784 |
This research study is being conducted through the University of Pittsburgh Cancer Institute (UPCI). It will evaluate the concentrations of Gleevec®, 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.
Condition | Intervention |
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Healthy |
Drug: Imatinib mesylate Dietary Supplement: calcium carbonate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Effect of Calcium Supplements on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS 280) (UPCI 08-072) |
Estimated Enrollment: | 12 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
On an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 15; and Gleevec® once daily on days 1 and 15 (i.e., Gleevec® alone on day 1, and combination of Gleevec® and calcium supplement on day 15).
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Drug: Imatinib mesylate
Dosage form: tablets Dosage: 400 mg Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
Dietary Supplement: calcium carbonate
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)
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2
On an 18-day schedule, calcium supplement (Tums Ultra 1000®) once daily on day 1; and Gleevec® once daily on days 1 and 15 (i.e., combination of Gleevec® and calcium supplement on day 1, Gleevec® alone on day 15).
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Drug: Imatinib mesylate
Dosage form: tablets Dosage: 400 mg Frequency & duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)
Dietary Supplement: calcium carbonate
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)
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This is an open-label, single-institution, randomized cross-over, fixed-schedule investigation of the effects of calcium carbonate on the pharmacokinetics (PK) of Gleevec® 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 Gleevec® alone on Day 1 and Gleevec® and calcium carbonate on Day 15, and the other half will receive Gleevec® and calcium carbonate on Day 1 and Gleevec® alone on Day 15, determined by randomization of subjects receiving either the combination or Gleevec® alone during the first visit. Doses will be 400 mg Gleevec® 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. Gleevec® PKwill be assessed after oral administration of 400 mg Gleevec® alone, and after oral administration of 400 mg Gleevec® 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan H. Beumer, PharmD, PhD | 412-623-3216 | beumerjh@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute / Clinical and Translational Research Centers (Hillman Cancer Center and Montefiore University Hospital locations) | Recruiting |
Pittsburgh, Pennsylvania, United States |
Principal Investigator: | Jan H. Beumer, PharmD, PhD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Jan H. Beumer, PharmD, PhD ) |
Study ID Numbers: | 08-072, CSTI571BUS 280, UPCI 08-072 |
Study First Received: | August 7, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00732784 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetics Healthy volunteers No condition Pharmacokinetics study |
Imatinib Calcium, Dietary Antacids |
Calcium Carbonate Healthy Protein Kinase Inhibitors |
Imatinib Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Antacids Calcium Carbonate Protein Kinase Inhibitors Pharmacologic Actions |