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Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir

NCT01582035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-02-17

No results posted yet for this study

Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and in Europe for the treatment of chronic hepatitis C infected patients.

Conditions

  • Hepatitis C

Interventions

DRUG

TMC647055

type=exact number, unit=mg, number=500, form=solution, route=oral use. Panel 1: TMC647055 is to be taken twice daily at a dose of 500 mg per day for 10 days.

DRUG

TMC647055

type=exact number, unit= mg, number=up to macimum 1000, form=solution, route=oral use. Panel 2: TMC647055 is to be taken twice daily at a maximum dose of 1000 mg for 10 or 14 days.

DRUG

TVR

type=exact number, unit= mg, number=1125, form=tablet, route=oral use. TVR is to be taken twice daily at a dose of 1125 mg for 10 days.

DRUG

TVR

type=exact number, unit=mg, number=1125 or 1500, form=tablet, route=oral use. In panel 2: TVR is to be taken twice daily at a dose of 1125 or 1500 mg for 10 or 14 days. In panel 3: TVR is to be taken twice daily at a dose of 1125 or 1500 mg for 6 days with on day 6 a morning dose only.

DRUG

TVR

type= exact number, unit= mg, number=750, form=tablet, route=oral use. TVR is to be taken every 8 hours at a dose of 750 mg for 12 weeks.

DRUG

PegFN

type= exact number, unit= mcg, number=180, form=solution, route=subcutaneous. PegIFN is to be injected once per week for 24 or 48 weeks.

DRUG

RBV

type=exact number, unit=mg, number=1000 or 1200, form=tablet, route=oral use. RBV is to be taken at 1000 or 1200 mg per day in 2 divided doses, depending on the weight for 24 or 48 weeks.

Sponsors & Collaborators

  • Janssen R&D Ireland

    lead INDUSTRY

Principal Investigators

  • Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582035 on ClinicalTrials.gov