NCT01017198

Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BIIB021 and Food	Assessing the effect of food use on BIIB021
DRUG	BIIB0121 and Antacid	Assessing the effect of antacid use on BIIB021

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-08-01
• Completion: 2011-01-01
• First posted: 2009-11-20
• Last updated: 2013-09-16

Locations

3 sites across 1 country: United States