The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX) - ROLEX

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•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

发起方

niversitair Medisch Centrum Sint Radboud