Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446316
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2007-03-08
Brief Title:
Effect of Antacids on Gleevec in Healthy Volunteers
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effect of Antacids Mg-Al-based on Imatinib Mesylate Gleevec Pharmacokinetics in Healthy Volunteers CSTI571BUS257
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 antacids 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 antacids Each volunteer will receive a 400 mg pill of Gleevec on two occasions One one occasion they will take the dose of Gleevec alone On another occasion they will take the Gleevec 15 minutes after taking a 20 mL dose of antacids 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 antacids
Detailed Description:
This is an open-label single-institution randomized cross-over fixed schedule study of the effects of Mg-Al-based antacids 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 magnesium-aluminum hydroxide-based antacid Maalox Gleevec will be administered at a dose of 400 mg and the antacid Maximum Strength MaaloxMax AntacidAnti-gas at a dose level of 20 mL equivalent to 1600 mg aluminum hydroxide and 1600 mg magnesium hydroxide Half of the subjects will receive Gleevec and antacid on day 15 and Gleevec alone on day 1 The other half will be treated in reverse order ie they will receive the combination of Gleevec and antacid on day 1 and Gleevec alone on day 15 The antacids 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 |
|---|---|---|---|
| CSTI571BUS257 | OTHER | Sponsor Protocol Number | None |