An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.
This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a
2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect
of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will
assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in
the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of
the antacid dosing day.
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.
Cycle 1, Day 3
United States: Food and Drug Administration
|Reseach Facility||Scottsdale, Arizona|
|Reseach Facility||Encinitas, California|
|Reseach Facility||San Antonio, Texas|