A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

March 31, 2013

Conditions
Healthy Volunteers
Interventions
DRUG

Avatrombopag maleate 40 mg

"Avatrombopag maleate 40 mg (2 x 20 mg tablets- all doses are expressed as avatrombopag, the amount of free base) given with 240 mL water in three single oral doses, one during each of three treatment periods. Participants randomized to one of three treatment sequences:~* Fed, Fed, Fasted; or~* Fed, Fasted, Fed; or~* Fasted, Fed, Fed~During the Fasted period, participants must have fasted for at least a 10-hour overnight fast and to refrain from eating for 4 hours.~During the Fed period, participants were allowed approximately 30 minutes to eat a low-fat breakfast and required to take the drug within 15 minutes of completion of breakfast.~Randomization Phase consists of three single-dose treatment periods:~Treatment Period 1 and 2 separated by a 7-day washout interval. Treatment Period 2 and 3 separated by a 28-day washout interval. Treatment period 3 and the Follow-up/ Termination Visit will be separated by a 30-day (+1 day) washout interval."

Trial Locations (1)

85283

Celerion, Tempe

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01759394 - A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal | Biotech Hunter | Biotech Hunter