Interaction Between Paroxetine and Telaprevir

NCT01841502 | Terminated Phase 2

• 1 other identifier: AKF UMCN 12.02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Hepatitis C Infection; Depression

Keywords

telaprevir; paroxetine; interaction; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• paroxetine area under the curve (AUC)

  paroxetine AUC will be compared intrasubject: day 14 + telaprevir / day -1 (without telaprevir)

  day -1 and day 14

Secondary Outcomes (4)

• paroxetine Cmax and C24

  Day -1 and Day 14

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Day -1 to Day 28

• short term HCV RNA response

  week 4

• telaprevir area under the curve (AUC)

  Day 14

Study Arms (2)

paroxetine alone

ACTIVE COMPARATOR

paroxetine 20 mg tablet once daily oral

Drug: Paroxetine

paroxetine + telaprevir

EXPERIMENTAL

paroxetine 20 mg tablet once daily + telaprevir 1125 mg (3 tablets 375mg) twice daily oral

Drug: Paroxetine; Drug: telaprevir

Interventions

Paroxetine DRUG

paroxetine 20 mg once daily

paroxetine + telaprevir; paroxetine alone

telaprevir DRUG

telaprevir 1125 mg twice daily

paroxetine + telaprevir

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Janssen, LP: collaborator

Study Sites (7)

Academic Medical Centre Amsterdam

Amsterdam, Netherlands

Location

GGD Amsterdam

Amsterdam, Netherlands

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

University Medical Centre Groningen

Groningen, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Maasstadziekenhuis

Rotterdam, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Related Links

• dissertation page 185-192

MeSH Terms

Conditions

Hepatitis C; Depression

Interventions

Paroxetine; telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Burger, PharmD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 26, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

NL (7)