Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CSTI571BUS258 | Other Identifier | Sponsor Protocol Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a research study that will investigate the effects of proton pump inhibitors (often used to treat stomach upset) on GleevecĀ® (a drug that is FDA-approved to treat some types of cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to complete the study. This research study will compare GleevecĀ® in the body when taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg pill of GleevecĀ® on two occasions. On one occasion they will take the dose of GleevecĀ® alone (without PPI). On another occasion, they will take the GleevecĀ® after taking 40 mg of PPI daily by mouth for six days. Several blood samples will be drawn to measure the concentrations of GleevecĀ® and its breakdown products in the blood, with and without the influence of PPI.
This is an open-label, single-institution, randomized cross-over, fixed schedule study of the effects of proton pump inhibitors (PPI) on Imatinib Mesylate (GleevecĀ®) pharmacokinetics. Healthy volunteers will be recruited to participate in this study such that twelve subjects (6 men / 6 women) will complete the study. GleevecĀ® pharmacokinetics will be assessed after oral administration of GleevecĀ® and after oral administration of GleevecĀ® with concomitant administration of PPI (PrilosecĀ® Delayed-Release Capsules). GleevecĀ® will be administered at a dose of 400 mg, and the PPI (PrilosecĀ®) at a dose level of 40 mg daily for 6 consecutive days. Half of the subjects will receive PrilosecĀ® starting 5 days before Day 1 through Day 1 along with GleevecĀ® on Day 1, and GleevecĀ® alone on Day 15. The other half will receive PrilosecĀ® on Days 10-15, along with GleevecĀ® on Day 15, and GleevecĀ® alone on Day 1. On days that both drugs are administered, the PrilosecĀ® will be administered 15 minutes before the GleevecĀ® dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | On an 18-day schedule, Omeprazole (PPI) once daily on days 10 through 16; and GleevecĀ® once daily on days 1 and 15 (i.e., GleevecĀ® alone on day 1, and combination of GleevecĀ® and PPI on day 15). |
|
| B | Other | On an 18-day schedule, Omeprazole (PPI) once daily on days -4 through 1; and GleevecĀ® once daily on days 1 and 15 (i.e., combination of GleevecĀ® and PPI on day 1, GleevecĀ® alone on day 15). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib Mesylate | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To define the effect of omeprazole administration on the pharmacokinetics (in particular the area under the GleevecĀ® plasma concentration versus time curve) of GleevecĀ® in healthy volunteers. | PK blood samples are drawn from each subject at time 0 (before each dose of GleevecĀ®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hrs after adminstration of GleevecĀ®. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan H. Beumer, PharmD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations) | Pittsburgh | Pennsylvania | 15232 / 15213 | United States |
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D009853 | Omeprazole |
| D054328 | Proton Pump Inhibitors |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Omeprazole | Drug | Dosage form: capsules Dosage: 40 mg Frequency: On an 18-day schedule, once daily day 10 through day 16 (for Arm A); or once daily day -4 through day 1 (for Arm B) |
|
|
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |