Effect of Calcium on Gleevec Pharmacokinetics (PK) in Healthy Volunteers
This study is ongoing, but not recruiting participants.
Sponsor:
Jan Beumer
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Jan Beumer, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00732784
First received: August 7, 2008
Last updated: November 9, 2012
Last verified: November 2012
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Purpose
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 |
|---|---|
|
Healthy |
Drug: Imatinib mesylate Dietary Supplement: calcium carbonate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Calcium Supplements on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS 280) (UPCI 08-072) |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- To define the effect of administration of a calcium salt (calcium carbonate) on the PK (in particular the area under the imatinib plasma concentration versus time curve) of imatinib (Gleevec®) in healthy volunteers. [ Time Frame: PK blood samples are drawn from each subject at time 0 (before each dose of Gleevec®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 48, and 72 hrs after adminstration of Gleevec®. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
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)
Other Names:
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)
Other Name: Tums Ultra 1000®
|
|
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).
|
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)
Other Names:
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)
Other Name: Tums Ultra 1000®
|
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 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 10-hour outpatient dosing visits and six brief outpatient visits are required to accommodate all study procedures.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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. For the purposes of this protocol, "clinically significant" is defined as any history or indication of illness or disease, such as those listed above.
- 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. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 7 days 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).
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732784
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center location) | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
Sponsors and Collaborators
Jan Beumer
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Jan H. Beumer, PharmD, PhD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Jan Beumer, Principal Investigator, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00732784 History of Changes |
| Other Study ID Numbers: | 08-072, CSTI571BUS 280, UPCI 08-072 |
| Study First Received: | August 7, 2008 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
Pharmacokinetics Healthy volunteers No condition Pharmacokinetics study |
Additional relevant MeSH terms:
|
Calcium, Dietary Calcium Carbonate Imatinib Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
Antacids Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013