Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate

Summary

The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.

Timeline

Start

2012-04

Primary completion

2012-10

Completion

2012-10

Outcome

Mixed primary results

registry analysis (superiority or other test); BG00012 vs BG00012 + ASA; Mean difference -1.9 (95% CI -3.0 to -0.9) NCT01568112 ↗

registry analysis (superiority or other test); BG00012 vs BG00012 + ASA; Difference in percentage -9 (95% CI -30.8 to 12.9) NCT01568112 ↗

Publications

• Results O'Gorman J, Russell HK, Li J, Phillips G, Kurukulasuriya NC, Viglietta V. Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. Clin Ther. 2015 Jul 1;37(7):1402-1419.e5. doi: 10.1016/j.clinthera.2015.03.028. Epub 2015 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASA	Unknown	325 mg	—
Subject	dimethyl fumarate	Unknown	240 mg	Oral

Indications

No indication recorded.