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

Radboud University Nijmegen Medical Centre0 个研究点目标入组 3 人开始时间: 2013年3月20日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•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 re-spectively 8.0 mM).
•8. Poor- or ultrarapid metabolizer CYP2D6

发起方

Radboud University Nijmegen Medical Centre