Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

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.

Trial Locations (2)

Unknown

Berlin

München

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT01582035 - Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir | Biotech Hunter | Biotech Hunter