Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331565
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-05-29
Brief Title:
Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin
Sponsor:
University of Oslo School of Pharmacy
Organization:
University of Oslo School of Pharmacy
Study Overview
Official Title:
Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Altered bioavailability of drugs will potentially affect both drug efficacy as well as safety In patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considerably reconstructed and a change in drug bioavailability is very likely Getting further knowledge on important mechanisms responsible for altered bioavailability would help in predicting clinically relevant consequences on different drugs
In the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability Atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well
In addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects
In the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability Atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well
In addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects
Detailed Description:
The primary objective of the study is to compare the effect of gastric bypass and BPDDS operations on atorvastatin bioavailability
Secondary objectives are to determine the relative change in atorvastatin bioavailability following gastric bypass as well as BPDDS operations In addition will the individual CYP3A4 CYP3A5 and P-gp activity in the different organs from where biopsies can be obtained be descriptively compared with atorvastatin pharmacokinetic variables
Secondary objectives are to determine the relative change in atorvastatin bioavailability following gastric bypass as well as BPDDS operations In addition will the individual CYP3A4 CYP3A5 and P-gp activity in the different organs from where biopsies can be obtained be descriptively compared with atorvastatin pharmacokinetic variables
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