32
Participants
Start Date
October 31, 2011
Primary Completion Date
November 30, 2011
Study Completion Date
November 30, 2011
INX-08189 50 mg QD X 5 days
Cohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose.
INX-08189 / Victrelis 800 mg TID X three days
Cohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7)
Victrelis 800 mg TID x 3 days
In Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2).
Victrelis 800 mg TID with INX-08189 50 mg QD
Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7).
Placebo with Victrelis 800 mg
During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
Cohort 2: Victrelis 800 mg with Placebo
During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
Prism Research, LLC, Saint Paul
Lead Sponsor
Bristol-Myers Squibb
INDUSTRY