Alternate Dosing Regimens of BG00012 in Healthy Volunteers

Phase 1 Completed 56 enrolled Biogen

RandomizedFactorialDouble-blindBasic science

Summary

The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo

Timeline

Start: 2011-02-01
Primary completion: 2011-03-18
Completion: 2011-03-18

Publications

Sheikh SI, Nestorov I, Russell H, O'Gorman J, Huang R, Milne GL, Scannevin RH, Novas M, Dawson KT. Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers. Clin Ther. 2013 Oct;35(10):1582-1594.e9. doi: 10.1016/j.clinthera.2013.08.009.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	325 mg	—
Subject	dimethyl fumarate	Unknown	720 mg	Oral

Indications

No indication recorded.