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
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, 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|
- Area under the plasma concentration-time course profile From Time = 0 to time extrapolated to infinity (AUC [0-inf]) [ Time Frame: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose ]AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: predose (-60 minutes), 1, 2, 3, 4, 5, 6, 7, 8, 12, 18, 24, 36, 48, 72, and 96 hours postdose ]
|Study Start Date:||October 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: Avatrombopag maleate 40 mg||
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:
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.
Other Name: E5501
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759394
|United States, Arizona|
|Tempe, Arizona, United States, 85283|
|Principal Investigator:||Mark Allison, MD||Eisai Inc.|