Trial · NCT00661141
Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
NCT00661141, Phase 2, Completed, Amgen; results first posted 2017-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism. Trials, record NCT00661141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
- NCT number
- NCT00661141
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
- Interventions
- Antizol, Placebo, Ethanol
- First posted
- 2008-04-18
- Last updated
- 2024-12-27
- Results first posted
- 2017-09-15
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Study Day 0 through Study Visit Day 7 | 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. |
| Secondary | Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: Dose-Normalized (DN) Cmax | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: Time to Cmax (Tmax) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t]) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: DN AUC(0-t) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞]) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: DN AUC(0-∞) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: Percentage of AUC0-∞ Obtained by Extrapolation (AUC%Extrap) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | |
| Secondary | PK of 4-MP: Half-Life (T1/2) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Study Day 0 through Study Visit Day 7 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | ng/mL | MEAN |
| SECONDARY | PK of 4-MP: Dose-Normalized (DN) Cmax | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | (ng/mL)/mg | MEAN | |
| SECONDARY | PK of 4-MP: Time to Cmax (Tmax) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | hours | MEDIAN |
| SECONDARY | PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t]) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | ng*hr/mL | MEAN |
| SECONDARY | PK of 4-MP: DN AUC(0-t) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | (ng*hr/mL)/mg | MEAN |
| SECONDARY | PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞]) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | ng*hr/mL | MEAN |
| SECONDARY | PK of 4-MP: DN AUC(0-∞) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | (ng*hr/mL)/mg | MEAN |
| SECONDARY | PK of 4-MP: Percentage of AUC0-∞ Obtained by Extrapolation (AUC%Extrap) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | percentage | MEAN |
| SECONDARY | PK of 4-MP: Half-Life (T1/2) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | hours | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Antizol 1.0 mg/kg | Any AE | 13 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Antizol 3.0 mg/kg | Any AE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Antizol 5.0 mg/kg | Any AE | 8 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Pooled Placebo | Any AE | 21 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Overall | Any AE | 28 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Antizol 1.0 mg/kg | Mild AE | 13 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Antizol 3.0 mg/kg | Mild AE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Antizol 5.0 mg/kg | Mild AE | 8 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Pooled Placebo | Mild AE | 19 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Overall | Mild AE | 28 | Participants |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Antizol 1.0 mg/kg, Then Placebo | 8 | |
| Overall Study | STARTED | Placebo, Then Antizol 1.0 mg/kg | 8 | |
| Overall Study | STARTED | Antizol 3.0 mg/kg, Then Placebo | 4 | |
| Overall Study | STARTED | Placebo, Then Antizol 3.0 mg/kg | 4 | |
| Overall Study | STARTED | Antizol 5.0 mg/kg, Then Placebo | 4 | |
| Overall Study | STARTED | Placebo, Then Antizol 5.0 mg/kg | 4 | |
| Overall Study | Administered 30 Minutes Prior to Ethanol | Antizol 1.0 mg/kg, Then Placebo | 6 | |
| Overall Study | Administered 30 Minutes Prior to Ethanol | Placebo, Then Antizol 1.0 mg/kg | 6 | |
| Overall Study | Administered 30 Minutes Prior to Ethanol | Antizol 3.0 mg/kg, Then Placebo | 2 | |
| Overall Study | Administered 30 Minutes Prior to Ethanol | Placebo, Then Antizol 3.0 mg/kg | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Antizol 1.0 mg/kg | 5 | 16 | |
| other | Headache | Nervous system disorders | Antizol 3.0 mg/kg | 1 | 8 | |
| other | Headache | Nervous system disorders | Antizol 5.0 mg/kg | 3 | 8 | |
| other | Headache | Nervous system disorders | Pooled Placebo | 7 | 32 | |
| other | Headache | Nervous system disorders | Overall | 15 | 32 | |
| other | Dysgeusia | Nervous system disorders | Antizol 1.0 mg/kg | 8 | 16 | |
| other | Dysgeusia | Nervous system disorders | Antizol 3.0 mg/kg | 0 | 8 | |
| other | Dysgeusia | Nervous system disorders | Antizol 5.0 mg/kg | 0 | 8 | |
| other | Dysgeusia | Nervous system disorders | Pooled Placebo | 0 | 32 | |
| other | Dysgeusia | Nervous system disorders | Overall | 8 | 32 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antizol 1.0 mg/kg | ||
| Total, all-cause mortality | Antizol 3.0 mg/kg | ||
| Total, all-cause mortality | Antizol 5.0 mg/kg | ||
| Total, all-cause mortality | Pooled Placebo | ||
| Total, all-cause mortality | Overall | ||
| Total, other adverse events | Antizol 1.0 mg/kg | 13 | 16 |
| Total, other adverse events | Antizol 3.0 mg/kg | 6 | 8 |
| Total, other adverse events | Antizol 5.0 mg/kg | 8 | 8 |
| Total, other adverse events | Pooled Placebo | 21 | 32 |
| Total, other adverse events | Overall | 28 | 32 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00661141
GET https://conductscience.org/api/trials/v1/NCT00661141/registered?page=2