Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01346800
Status:
COMPLETED
Last Update Posted:
2011-10-06
First Post:
2011-04-21
Brief Title:
Pharmacokinetic Interaction Between Ritonavir and Prasugrel in Healthy Volunteers
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-04
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:
HIV patients are at particular risk to develop cardiovascular disease CVD as they exhibit multiple known risk factors for CVD Of specific concern is the fact that use of the non nucleosidic reverse transcriptase inhibitors NNRTI andor protease inhibitors PI drug classes is associated with dyslipidemia known to increase the risk of coronary heart disease particularly among older subjects with normalized CD4 cell counts and suppressed HIV replication HIV patients could thus potentially receive anti-aggregant therapy concomitantly with their antiretroviral treatment Prasugrel is an anti-aggregating agent indicated to prevent the recurrence of ischemic events after coronary arteries stenting It is a pro-drug mainly metabolized by cytochromes P450 CYP 3A and 2B6 and to a lesser extent by CYP2C9 and 2C19 Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in anti-HIV therapy The aim of the present study is to assess the potential drug-drug interaction between prasugrel and the CYP3A2B6 inhibitor ritonavir Ten healthy volunteers will receive prasugrel 10mg alone or after 100mg ritonavir The effect of ritonavir on prasugrel pharmacokinetics will be assessed The two sessions will be separated by a one-week wash out period During each session CYP3A 2B6 2C9 and 2C19 activities will be assessed by a micrococktail approach with microdoses of midazolam bupropion flurbiprofen and omeprazole The pharmacokinetics of prasugrel active metabolite will be assessed during the two sessions
Detailed Description:
None
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