Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03563287
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2018-06-08
Brief Title:
Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs
Sponsor:
University of Eastern Finland
Organization:
University of Eastern Finland
Study Overview
Official Title:
Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery
Status:
COMPLETED
Status Verified Date:
2018-06
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:
Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass RYGB bariatric surgery drug bioavailability after the surgery can be altered Therefore post-operative dose adjustment in these patients can be required
The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass LRYGB surgery on drug pharmacokinetics and cytochrome P450 CYP mediated metabolism using a cocktail of nine CYP probe drugs
The cocktail covers nine main CYP enzymes melatonin CYP1A2 nicotine CYP2A6 bupropion CYP2B6 repaglinide CYP2C8 losartan CYP2C9 omeprazole CYP2C19CYP3A4 dextromethorphan CYP2D6 chlorzoxazone CYP2E1 midazolam CYP3A4
The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB In the study the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls
The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass LRYGB surgery on drug pharmacokinetics and cytochrome P450 CYP mediated metabolism using a cocktail of nine CYP probe drugs
The cocktail covers nine main CYP enzymes melatonin CYP1A2 nicotine CYP2A6 bupropion CYP2B6 repaglinide CYP2C8 losartan CYP2C9 omeprazole CYP2C19CYP3A4 dextromethorphan CYP2D6 chlorzoxazone CYP2E1 midazolam CYP3A4
The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB In the study the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None