Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism

Completed · Phase 2 · Has a placebo group

Conditions studied: Aldehyde Dehydrogenase-2 (ALDH2) Deficiency

In brief

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.

Key facts

Study ID

NCT00661141

Run by

Amgen

People needed

32

Starts

2008-04-01

Expected to finish

2008-06-01

Last updated by the study team

2024-12-27

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed informed consent
• Age 21 to 50 years
• Subject of Japanese descent
• History of flushing, with or without palpitations, or nausea (Alcohol Sensitivity Screening Test ≥ 3.1) following occasional or inadvertent ethanol consumption either currently or in the past
• Subjects must be healthy volunteers with no other clinically relevant abnormalities as determined by medical history, blood chemistry, complete blood count (CBC), urinalysis,and 12-lead electrocardiogram (ECG)
• Positive skin ethanol patch test (100 μL of 70% ethanol on a lint pad applied to skin for 7 minutes results in an area of erythema)
• For Cohort 4, enrolled subjects were either homozygous or heterozygous for the ALDH2*2 genotype as assessed by genotyping at Screening

You may not qualify if…

• Vaccination within 2 weeks of Day 1
• Current respiratory disease or a past history of chronic respiratory disease, or current smoker within last six months
• Any one of the following Screening ECG findings:
• QTc (Bazett) interval duration greater than 450 msec (male) or 470 msec (female), or
• QRS interval greater than 120 msec, or
• PR interval greater than 220 msec
• History or evidence of drug or alcohol abuse or regular consumption of more than 8 units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from non study alcohol during the 36 hours prior to dose administration and until completion of blood sampling on Day 7
• Subjects who have donated blood totalling more than 550 mL within the 3 months prior to Day 1
• Use of any prescription medication other than oral contraceptives during the 14 days prior to Day 1, unless approved by both the Principal Investigator (PI) and the Sponsor
• Inability to abstain from smoking any tobacco product from within prior to 2 hours of blood sampling to after 2 hours of blood sampling during the study period.
• Use of any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to Day 1 unless approved by both the PI and the Sponsor
• Chronic use of pain medications
• Administration of an investigational agent within the last 30 days (or within a period of less than 5 times the agent's half-life, whichever is longer) prior to Day 1
• Major surgery within 60 days prior to Day 1, or any planned surgery or medical procedure during the study period (through Day 7)
• Positive alcohol breath-test or Positive drug screen (e.g., opiates, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamines) during screening or at Day 0 Check-In
• Known hypersensitivity reaction to Antizol® or other pyrazoles, tomato juice
• Abnormal laboratory results, including:
• WBC ≤3.5 × 109/L or neutrophil count ≤2.0 × 10\^9/L
• Hemoglobin <12.0 or >16.0 gm/dL
• Creatinine ≥2 mg/dL
• Total bilirubin ≥2 mg/dL
• Alanine aminotransferase and/or aspartate aminotransferase ≥2 times the upper limit of normal
• PaO2 ≤95% on room air by pulse oximetry
• Urine dipstick positive for protein, blood, ketones, glucose or leukocyte esterase
• Any other clinically significant abnormal result for hematology, clinical chemistry, or urinalysis at screening or check-In

Where it is running

• Covance Honolulu CRU — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.