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Pharmacokinetic Interaction Between Ritonavir and Prasugrel in Healthy Volunteers

NCT ID: NCT01346800

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-09-30

Brief Summary

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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) and/or 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 CYP3A/2B6 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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Prasugrel 10mg po

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4

Prasugrel 10mg po + ritonavir 100mg po

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4

Ritonavir

Intervention Type DRUG

Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4 in presence of ritonavir

Interventions

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Prasugrel

Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4

Intervention Type DRUG

Ritonavir

Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4 in presence of ritonavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged from 18 to 60 years
* BMI between 18 and 25
* Understanding of French language and able to give an inform consent.

Exclusion Criteria

* smoker
* hypersensitivity to prasugrel or ritonavir or constituents of the tablets - - regular alcohol consumption
* concomitant disease
* intake of any drug or particular food (grapefruit) that can affect or metabolized by the CYP3A, 2C19, 2B6 and 2C9 within 1 month before the study
* pathologies or drugs associated with an increased bleeding risk such as aspirin, non-steroidal anti-inflammatory drugs, steroids and serotonin reuptake inhibitors (in the last 10 days before the start of the study)
* bleeding familial history or antecedent or haemorrhagic disease
* previous gastro-intestinal ulcer or active ulcer
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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University Hospitals, Geneva

Principal Investigators

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Jules A Desmeules, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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MICRO-PRASU-RITONAVIR

Identifier Type: -

Identifier Source: org_study_id