The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)
- Conditions
- depressionHCV100196541004743810027946
- Registration Number
- NL-OMON38871
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
1. Subject is at least 18 and not older than 65 years of age at screening.;2. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.;3. Subject has a chronic HCV infection with genotype 1. ;4. Subject is eligible for telaprevir containing HCV treatment.;5. Subject is on a stable dose of 20 mg paroxetine QD for at least 4 weeks.
1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.;2. Pregnant female (as confirmed by an HCG test performed less than 6 weeks before Day -1) or breast-feeding female. Female subjects of childbearing potential without adequate contracep-tion, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout.;3. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. ;4. Inability to understand the nature and extent of the trial and the procedures required.;5. Participation in a drug trial within 60 days prior to the first dose of telaprevir.;6. Use of relevant concomitant medication, as assessed by a hos-pital pharmacist (member of the study team). ;7. Hemoglobin < 12 g/dL (females) or < 13 g/dL (males) (7.4 respectively 8.0 mM). ;8. Poor- or ultrarapid metabolizer CYP2D6
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Geometric Mean Ratio (GMR) of the area under the curve (AUC) of paroxetine in<br /><br>combination with telaprevir versus paroxetine alone.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Geometric Mean Ratio (GMR) of paroxetine Cmax en C24h of paroxetine in<br /><br>combination with telaprevir versus paroxetine alone.<br /><br><br /><br>Adverse events of combined use of paroxetine 20mg QD with telaprevir-containing<br /><br>HCV treatment.<br /><br><br /><br>HCV RNA response at week 4 of telaprevir-containing HCV treatment with<br /><br>concomitant use of paroxetine.<br /><br><br /><br>Telaprevir pharmacokinetics (AUC0-12h, Cmax C12h) of telaprevir in combination<br /><br>with paroxetine.</p><br>