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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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 (all doses are expressed as avatrombopag, the amount of free base) to healthy subjects Receiving a low-fat Meal.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2013-01-03
• Last updated: 2013-10-31

Locations

1 site across 1 country: United States