chronic hepatitis C infection with depression MedDRA version: 15.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Incivo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TELAPREVIR
CAS Number: 402957-28-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.;Primary end point(s): Geometric Mean Ratio (GMR) of the area under the curve (AUC) of paroxetine in combination with telaprevir versus paroxetine alone.;Timepoint(s) of evaluation of this end point: Day -1 and Day 14.;Secondary Objective: To determine the ratio of the geometric means (medians) of the paroxetine PK parameters Cmax and C24h for the combination therapy of telaprevir (1125 mg BID) and paroxetine (20 mg QD) versus paroxetine (20 mg QD) alone. To determine the short-term safety of combined use of paroxetine 20mg QD with telaprevir-containing HCV treatment. To assess the short-term HCV RNA response of telaprevir-containing HCV treatment (week 4 response) with concomitant use of paroxetine. To assess telaprevir pharmacokinetics 1125 mg BID (AUC0-12h, Cmax, C12h) when co-administered with paroxetine 20mg QD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Geometric Mean Ratio (GMR) of paroxetine Cmax en C24h of paroxetine in combination with telaprevir versus paroxetine alone. Adverse events of combined use of paroxetine 20mg QD with telaprevir-containing HCV treatment. HCV RNA response at week 4 of telaprevir-containing HCV treatment with concomitant use of paroxetine. Telaprevir pharmacokinetics (AUC0-12h, Cmax C12h) of telaprevir in combination with paroxetine. ;Timepoint(s) of evaluation of this end point: PK paroxetine Day -1 and Day 14. Adverse events entire study. HCV RNA response week 4. Telaprevir PK at Day 14. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Pharmacy
Radboud University Medical Centre
Outcome results
None listed