NCT01281111

Alternate Dosing Regimens of BG00012 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire \[Norquist 2007\], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dimethyl Fumarate (BG00012)
DRUG	Aspirin
DRUG	BG00012 matching placebo
DRUG	ASA matching placebo

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-03-18
• Completion: 2011-03-18
• First posted: 2011-01-21
• Last updated: 2023-08-23

Locations

1 site across 1 country: United States