drugset / Trial / NCT01924832

BG00012 Regional Absorption Study

NCT01924832

Phase 1 Completed 32 enrolled Biogen
Non-randomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.

Timeline

Start
2013-08
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject dimethyl fumarate Unknown 120 mg
Subject dimethyl fumarate Unknown 240 mg

Indications

No indication recorded.