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Sponsored by: |
Bennu Pharmaceuticals Inc. |
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Information provided by: | Bennu Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00661141 |
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.
Condition | Intervention | Phase |
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Acetaldehyde Toxicity ALDH2 Deficiency Altered Ethanol Metabolism |
Drug: fomepizole; |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Phase IIa, Prospective, Randomized, Blinded, Intra-Subject Controlled, Dose Escalation Study of Fomepizole for Mitigation of Acetaldehyde Related Toxicity in Human Subjects With Altered Ethanol Metabolism With Concomitant Ethanol Exposure |
Estimated Enrollment: | 32 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Approximately 32 subjects will be enrolled in ascending dosing cohorts of 8 subjects each. Each subject will receive an oral dose of study drug (fomepizole or placebo) with concomitant ethanol with group assignment in a randomized 1:1:1:1 ratio (2 subjects each group) on Study Day 1. Each subject is their own intra-subject control with the alternative study drug (fomepizole or placebo) administered on the next day (Study Day 2). Four subjects in each cohort will receive study drug (fomepizole or placebo) administered 30 minutes prior to ethanol, 4 with study drug (fomepizole or placebo) administered 30 minutes after ethanol. The study will assess safety and tolerability of fomepizole and the PK/PD of 4-MP, ethanol and acetaldehyde in the subject population.
Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Any one of the following Screening ECG findings:
Abnormal laboratory results, including:
United States, California | |
Covance Honolulu CRU | Recruiting |
Honolulu, California, United States, 96813 | |
Contact: Paul Bogner 808-441-6327 | |
Principal Investigator: John Ruckle, MD |
Principal Investigator: | James Ruckle, MD | Covanance Honolulu CRU |
Responsible Party: | Bennu Pharmaceuticals Inc. ( Thomas E. Daley ) |
Study ID Numbers: | BP1-01-01 |
Study First Received: | April 16, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00661141 |
Health Authority: | United States: Institutional Review Board |
acetaldehyde ethanol ALDH2 |
Fomepizole Ethanol |
Anti-Infective Agents Anti-Infective Agents, Local Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Protective Agents Central Nervous System Agents Pharmacologic Actions Antidotes |