Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with
alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited
metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath
and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol.
Long-term, serious health risks have been associated with repeated exposure to acetaldehyde,
a carcinogen, among ALDH2-deficient individuals.
Phase:
Phase 2
Details
Lead Sponsor:
Horizon Pharma USA, Inc. Raptor Pharmaceuticals Inc.