Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446004
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2007-03-08
Brief Title:
Effect of a Proton Pump Inhibitor on Gleevec in Healthy Volunteers
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effect of a Proton Pump Inhibitor Omeprazole Prilosec on Imatinib Mesylate Gleevec Pharmacokinetics in Healthy Volunteers CSTI571BUS258
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study that will investigate the effects of proton pump inhibitors often used to treat stomach upset on Gleevec 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 Gleevec in the body when taken with and without proton pump inhibitors PPI Each volunteer will receive a 400 mg pill of Gleevec on two occasions On one occasion they will take the dose of Gleevec alone without PPI On another occasion they will take the Gleevec after taking 40 mg of PPI daily by mouth for six days Several blood samples will be drawn to measure the concentrations of Gleevec and its breakdown products in the blood with and without the influence of PPI
Detailed Description:
This is an open-label single-institution randomized cross-over fixed schedule study of the effects of proton pump inhibitors PPI on Imatinib Mesylate Gleevec pharmacokinetics Healthy volunteers will be recruited to participate in this study such that twelve subjects 6 men 6 women will complete the study Gleevec pharmacokinetics will be assessed after oral administration of Gleevec and after oral administration of Gleevec with concomitant administration of PPI Prilosec Delayed-Release Capsules Gleevec will be administered at a dose of 400 mg and the PPI Prilosec at a dose level of 40 mg daily for 6 consecutive days Half of the subjects will receive Prilosec starting 5 days before Day 1 through Day 1 along with Gleevec on Day 1 and Gleevec alone on Day 15 The other half will receive Prilosec on Days 10-15 along with Gleevec on Day 15 and Gleevec alone on Day 1 On days that both drugs are administered the Prilosec will be administered 15 minutes before the Gleevec dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CSTI571BUS258 | OTHER | Sponsor Protocol Number | None |