This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Assessing the effect of food use on BIIB021
Assessing the effect of antacid use on BIIB021
Reseach Facility
Scottsdale, Arizona, United States
Reseach Facility
Encinitas, California, United States
Reseach Facility
San Antonio, Texas, United States
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.
Time frame: Cycle 1, Day 3
To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions
Time frame: Cycle 1, Day 8 and Day 10
To evaluate the safety and tolerability of BIIB021
Time frame: 6 months
To evaluate the antitumor activity of BIIB021
Time frame: 6 months
To evaluate the effect of BIIB021 on pharmacodynamic biomarkers.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.