Alternate Dosing Regimens of BG00012 in Healthy Volunteers
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2011 |
| End Date: | June 2011 |
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
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.
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.
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