Interaction Between Paroxetine and Telaprevir

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Hepatitis C (HCV) infected patients are often in need for an antidepressant. The introduction of Direct Acting Antivirals such as telaprevir has greatly improved treatment outcome of HCV infected patients.Telaprevir has been studied with one antidepressant, escitalopram: plasma concentrations of the antidepressant were reduced by 35% and without dose adjustment this may lead to inadequate treatment of depressive symptoms. There is a need for more data on telaprevir drug interactions with other antidepressants.

For a number of reasons, paroxetine may be a good candidate for use together with telaprevir-containing HCV treatment.

The interaction between paroxetine and telaprevir has not been studied before.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Janssen, LP
• Treatments: Paroxetine

Criteria

Inclusion Criteria:

• Subject is at least 18 and not older than 65 years at screening.

• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

• Subject has a chronic HCV infection with genotype 1.

• Subject is eligible for telaprevir containing HCV treatment.

• Subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.

Exclusion Criteria:

• Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.

• Pregnant female (as confirmed by a human chorionic gonadotropin (HCG) test performed less than 6 weeks before Day -1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, 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.

• Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

• Inability to understand the nature and extent of the trial and the procedures required.

• Participation in a drug trial within 60 days prior to the first dose of telaprevir.

• Use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).

• Hemoglobin < 12 g/dL (females) or < 13 g/dL (males) (7.4 respectively 8.0 mM).

• Poor- or ultrarapid metabolizer CYP2D6 (based on genetic testing)