| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00661141 | Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism | PHASE2 | COMPLETED | 32 | — | — | Apr 1, 2008 | Jun 1, 2008 | Dec 27, 2024 | 1 | United States |
AEs were collected to evaluate the safety and tolerability of oral Antizol with concomitant ethanol administration in particitpants with symptoms of acetaldehyde toxicity associated with altered ethanol metabolism. AE: any untoward medical event that occurs following the first administration of study medication until the study participant's last study visit, whether or not the event is considered drug related. SAE: an event that meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of an exposed subject; is medically significant or an important medical event as assessed by investigator or sponsor; is, in the opinion of the investigator, an important medical event.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Antizol 1.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. |
| Cohort 2: Antizol 3.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. |
| Cohort 3: Antizol 5.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. |
| Cohort 4: Antizol 1.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 7.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. |
| Name | Type | Description |
|---|---|---|
| Antizol | DRUG | - |
| Placebo | DRUG | - |
| Ethanol | OTHER | oral dose of ethanol (0.5 g/kg) |
Inclusion Criteria: * 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 * Subjec...