Trial Outcomes & Findings for Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism (NCT NCT00661141)

NCT ID: NCT00661141

Last Updated: 2024-12-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: Study Day 0 through Study Visit Day 7
• Results posted on: 2024-12-27

Participant Flow

Although originally planned to receive Antizol 7.0 mg/kg, participants in Cohort 4 were dosed with study drug (Antizol or placebo) at 1.0 mg/kg,the same level dosed for the Cohort 1 participants. As a result, Cohorts 1 and 4 were combined together in the data summary and statistical analyses.

Participant milestones

Measure	Antizol 1.0 mg/kg, Then Placebo Participants received Antizol 1.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.	Placebo, Then Antizol 1.0 mg/kg Participants received placebo treatment then Antizol 1.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.	Antizol 3.0 mg/kg, Then Placebo Participants received Antizol 3.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.	Placebo, Then Antizol 3.0 mg/kg Participants received placebo treatment then Antizol 3.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.	Antizol 5.0 mg/kg, Then Placebo Participants received Antizol 5.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo, Then Antizol 5.0 mg/kg Participants received placebo treatment then Antizol 5.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
Overall Study STARTED	8	8	4	4	4	4
Overall Study Administered 30 Minutes Prior to Ethanol	6	6	2	2	4	4
Overall Study Administered 30 Minutes After Ethanol	2	2	2	2	0	0
Overall Study COMPLETED	8	8	4	4	4	4
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Antizol 1.0 mg/kg and Placebo n=16 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg and Placebo n=8 Participants Participants receive alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg and Placebo n=8 Participants Participants receive alternating study treatment (oral Antizol 5.0 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.	Total n=32 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	29 years n=7 Participants	34 years n=5 Participants	34 years n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized Japanese Ancestry	16 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized Born in Japan	10 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized Not Born in Japan	6 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Antizol 1.0 mg/kg n=16 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=8 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=8 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=32 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=32 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Moderate AE	2 Participants	0 Participants	0 Participants	5 Participants	7 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Life-Threatening/Disabling AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Any AE	13 Participants	6 Participants	8 Participants	21 Participants	28 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Mild AE	13 Participants	6 Participants	8 Participants	19 Participants	28 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Severe AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Possibly or Probably Related AE	13 Participants	6 Participants	5 Participants	18 Participants	27 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation AE Leading to Study Discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation Serious AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax)	2386 ng/mL Standard Deviation 625	1358 ng/mL Standard Deviation 359	5605 ng/mL Standard Deviation 1183	4680 ng/mL Standard Deviation 645	8623 ng/mL Standard Deviation 2674	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Dose-Normalized (DN) Cmax	38.3 (ng/mL)/mg Standard Deviation 15.9	18.9 (ng/mL)/mg Standard Deviation 4.65	27.6 (ng/mL)/mg Standard Deviation 3.05	28.0 (ng/mL)/mg Standard Deviation 4.26	30.2 (ng/mL)/mg Standard Deviation 11.0	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Time to Cmax (Tmax)	1.00 hours Interval 0.333 to 4.0	2.50 hours Interval 1.53 to 4.43	0.667 hours Interval 0.333 to 1.0	1.48 hours Interval 0.5 to 2.5	1.00 hours Interval 0.333 to 3.0	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t])	13804 ng*hr/mL Standard Deviation 4492	7409 ng*hr/mL Standard Deviation 1437	44942 ng*hr/mL Standard Deviation 17784	34310 ng*hr/mL Standard Deviation 14431	109298 ng*hr/mL Standard Deviation 30635	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: DN AUC(0-t)	223 (ng*hr/mL)/mg Standard Deviation 105	103 (ng*hr/mL)/mg Standard Deviation 16.6	231 (ng*hr/mL)/mg Standard Deviation 110	204 (ng*hr/mL)/mg Standard Deviation 83.1	378 (ng*hr/mL)/mg Standard Deviation 110	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=2 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=6 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞])	11035 ng*hr/mL Standard Deviation NA 1 participant had an assessment	7627 ng*hr/mL Standard Deviation 948	55452 ng*hr/mL Standard Deviation NA 1 participant had an assessment	57028 ng*hr/mL Standard Deviation NA 1 participant had an assessment	136871 ng*hr/mL Standard Deviation 43703	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=2 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=6 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: DN AUC(0-∞)	149 (ng*hr/mL)/mg Standard Deviation NA 1 participant had an assessment	122 (ng*hr/mL)/mg Standard Deviation 9.15	317 (ng*hr/mL)/mg Standard Deviation NA 1 participant had an assessment	334 (ng*hr/mL)/mg Standard Deviation NA 1 participant had an assessment	460 (ng*hr/mL)/mg Standard Deviation 129	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=2 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=6 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Percentage of AUC0-∞ Obtained by Extrapolation (AUC%Extrap)	16.8 percentage Standard Deviation NA 1 participant had an assessment	13.0 percentage Standard Deviation 0.606	3.31 percentage Standard Deviation NA 1 participant had an assessment	4.37 percentage Standard Deviation NA 1 participant had an assessment	13.2 percentage Standard Deviation 12.6	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=3 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=7 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Half-Life (T1/2)	2.72 hours Standard Deviation NA 1 participant had an assessment	3.11 hours Standard Deviation 1.80	5.37 hours Standard Deviation NA 1 participant had an assessment	5.76 hours Standard Deviation NA 1 participant had an assessment	9.26 hours Standard Deviation 4.93	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=2 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=6 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Apparent Clearance (CL/F)	6.70 L/hr Standard Deviation NA 1 participant had an assessment	8.23 L/hr Standard Deviation 0.618	3.15 L/hr Standard Deviation NA 1 participant had an assessment	2.99 L/hr Standard Deviation NA 1 participant had an assessment	2.35 L/hr Standard Deviation 0.782	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=2 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=6 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo Ethanol followed by placebo 30 minutes later.
PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F)	26.3 Liters Standard Deviation NA 1 participant had an assessment	24.7 Liters Standard Deviation 4.22	24.4 Liters Standard Deviation NA 1 participant had an assessment	24.9 Liters Standard Deviation NA 1 participant had an assessment	24.7 Liters Standard Deviation 9.91	—	—

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: Cmax	62.7 mg/dL Standard Deviation 10.1	70.3 mg/dL Standard Deviation 4.99	80.5 mg/dL Standard Deviation 5.20	43.3 mg/dL Standard Deviation 9.54	74.9 mg/dL Standard Deviation 21.9	59.3 mg/dL Standard Deviation 15.4	55.1 mg/dL Standard Deviation 14.5

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: DN Cmax	0.00195 (mg/dL)/mg Standard Deviation 0.000448	0.00198 (mg/dL)/mg Standard Deviation 0.000420	0.00243 (mg/dL)/mg Standard Deviation 0.000453	0.00155 (mg/dL)/mg Standard Deviation 0.000359	0.00261 (mg/dL)/mg Standard Deviation 0.000871	0.00193 (mg/dL)/mg Standard Deviation 0.000667	0.00175 (mg/dL)/mg Standard Deviation 0.000543

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: Tmax	1.50 hours Interval 0.5 to 2.5	0.833 hours Interval 0.467 to 1.07	0.500 hours Interval 0.5 to 0.5	1.42 hours Interval 0.333 to 2.0	0.500 hours Interval 0.333 to 1.5	0.500 hours Interval 0.333 to 2.5	1.01 hours Interval 0.833 to 2.0

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: AUC(0-t)	209 mg*hr/dL Standard Deviation 46.1	209 mg*hr/dL Standard Deviation 24.2	205 mg*hr/dL Standard Deviation 13.1	135 mg*hr/dL Standard Deviation 44.0	231 mg*hr/dL Standard Deviation 67.1	157 mg*hr/dL Standard Deviation 53.2	152 mg*hr/dL Standard Deviation 42.6

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: DN AUC(0-t)	0.00648 (mg*hr/dL)/mg Standard Deviation 0.00171	0.00585 (mg*hr/dL)/mg Standard Deviation 0.00115	0.00613 (mg*hr/dL)/mg Standard Deviation 0.000641	0.00483 (mg*hr/dL)/mg Standard Deviation 0.00155	0.00791 (mg*hr/dL)/mg Standard Deviation 0.00163	0.00508 (mg*hr/dL)/mg Standard Deviation 0.00194	0.00476 (mg*hr/dL)/mg Standard Deviation 0.00124

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=2 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=7 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=14 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=5 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: AUC(0-∞)	245 mg*hr/mL Standard Deviation 55.7	263 mg*hr/mL Standard Deviation 27.2	237 mg*hr/mL Standard Deviation 27.0	215 mg*hr/mL Standard Deviation 27.9	271 mg*hr/mL Standard Deviation 75.0	214 mg*hr/mL Standard Deviation 47.4	198 mg*hr/mL Standard Deviation 47.3

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=2 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=7 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=14 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=5 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: DN AUC(0-∞)	0.00760 (mg*hr/dL)/mg Standard Deviation 0.00199	0.00731 (mg*hr/dL)/mg Standard Deviation 0.000843	0.00705 (mg*hr/dL)/mg Standard Deviation 0.000437	0.00768 (mg*hr/dL)/mg Standard Deviation 0.000707	0.00917 (mg*hr/dL)/mg Standard Deviation 0.00166	0.00681 (mg*hr/dL)/mg Standard Deviation 0.00182	0.00617 (mg*hr/dL)/mg Standard Deviation 0.00120

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=2 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=7 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=14 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=5 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: AUC%Extrap	14.7 percentage Standard Deviation 4.95	20.5 percentage Standard Deviation 6.90	13.2 percentage Standard Deviation 4.89	20.0 percentage Standard Deviation 4.68	12.1 percentage Standard Deviation 6.13	13.4 percentage Standard Deviation 5.62	13.9 percentage Standard Deviation 4.85

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=2 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=16 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=5 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: T1/2	1.51 hours Standard Deviation 0.391	1.95 hours Standard Deviation 0.206	1.43 hours Standard Deviation 0.219	1.78 hours Standard Deviation 0.64	1.67 hours Standard Deviation 0.608	1.45 hours Standard Deviation 0.564	1.32 hours Standard Deviation 0.193

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=2 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=7 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=14 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=5 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: CL/F	140 dL/hr Standard Deviation 36.8	138 dL/hr Standard Deviation 14.3	142 dL/hr Standard Deviation 8.81	131 dL/hr Standard Deviation 12.0	112 dL/hr Standard Deviation 19.6	159 dL/hr Standard Deviation 51.8	167 dL/hr Standard Deviation 32.7

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=2 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=7 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=14 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=5 Participants Ethanol followed by placebo 30 minutes later.
PK of Ethanol: Vz/F	297 dL Standard Deviation 82.8	387 dL Standard Deviation 57.0	295 dL Standard Deviation 55.4	330 dL Standard Deviation 89.5	242 dL Standard Deviation 79.1	287 dL Standard Deviation 86.3	321 dL Standard Deviation 87.7

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: Cmax	59.6 µM Standard Deviation 34.4	37.6 µM Standard Deviation 26.9	50.9 µM Standard Deviation 52.8	55.9 µM Standard Deviation 52.2	40.0 µM Standard Deviation 16.6	60.3 µM Standard Deviation 34.8	42.7 µM Standard Deviation 30.6

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: DN Cmax	0.00181 µM/mg Standard Deviation 0.00101	0.00104 µM/mg Standard Deviation 0.000650	0.00157 µM/mg Standard Deviation 0.00167	0.00201 µM/mg Standard Deviation 0.00192	0.00138 µM/mg Standard Deviation 0.000542	0.00193 µM/mg Standard Deviation 0.00114	0.00141 µM/mg Standard Deviation 0.00112

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: Tmax	0.500 hours Interval 0.167 to 5.5	0.650 hours Interval 0.35 to 3.0	1.00 hours Interval 0.333 to 3.5	1.33 hours Interval 0.167 to 2.0	0.500 hours Interval 0.333 to 2.5	0.500 hours Interval 0.167 to 5.5	0.925 hours Interval 0.167 to 4.0

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: AUC(0-t)	178 µM*hr Standard Deviation 53.0	118 µM*hr Standard Deviation 56.4	155 µM*hr Standard Deviation 68.7	167 µM*hr Standard Deviation 84.4	128 µM*hr Standard Deviation 33.2	163 µM*hr Standard Deviation 61.3	139 µM*hr Standard Deviation 93.7

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=12 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=4 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=4 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=8 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=24 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=8 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: DN AUC(0-t)	0.00547 µM*hr/mg Standard Deviation 0.00148	0.00329 µM*hr/mg Standard Deviation 0.00144	0.00470 µM*hr/mg Standard Deviation 0.00230	0.00597 µM*hr/mg Standard Deviation 0.00293	0.00439 µM*hr/mg Standard Deviation 0.00100	0.00521 µM*hr/mg Standard Deviation 0.00204	0.00455 µM*hr/mg Standard Deviation 0.00332

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=9 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=3 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=5 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=12 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=4 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: AUC(0-∞)	234 µM*hr Standard Deviation 64.4	154 µM*hr Standard Deviation 63.3	297 µM*hr Standard Deviation NA 1 participant had an assessment	302 µM*hr Standard Deviation NA 1 participant had an assessment	188 µM*hr Standard Deviation 28.1	205 µM*hr Standard Deviation 71.1	227 µM*hr Standard Deviation 92.9

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=9 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=3 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=5 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=12 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=4 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: DN AUC(0-∞)	0.00682 µM*hr/mg Standard Deviation 0.00203	0.00432 µM*hr/mg Standard Deviation 0.00176	0.00929 µM*hr/mg Standard Deviation NA 1 participant had an assessment	0.0105 µM*hr/mg Standard Deviation NA 1 participant had an assessment	0.00626 µM*hr/mg Standard Deviation 0.00110	0.00616 µM*hr/mg Standard Deviation 0.00171	0.00752 µM*hr/mg Standard Deviation 0.00360

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=9 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=3 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=5 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=12 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=4 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: AUC%Extrap	19.0 percentage Standard Deviation 6.07	18.8 percentage Standard Deviation 8.11	13.1 percentage Standard Deviation NA 1 participant had an assessment	9.78 percentage Standard Deviation NA 1 participant had an assessment	24.7 percentage Standard Deviation 5.26	13.7 percentage Standard Deviation 5.29	14.5 percentage Standard Deviation 11.4

SECONDARY outcome

Timeframe: 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

Population: Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2.

Outcome measures

Measure	Antizol 1.0 mg/kg n=10 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=3 Participants Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=1 Participants Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=1 Participants Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.	Overall n=6 Participants Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Placebo Followed by Ethanol n=12 Participants Placebo followed by ethanol 30 minutes later.	Ethanol Followed by Placebo n=4 Participants Ethanol followed by placebo 30 minutes later.
PK of Acetaldehyde: T1/2	3.14 hours Standard Deviation 0.729	3.08 hours Standard Deviation 0.640	2.48 hours Standard Deviation NA 1 participant had an assessment	1.72 hours Standard Deviation NA 1 participant had an assessment	3.45 hours Standard Deviation 3.43	2.39 hours Standard Deviation 0.521	2.09 hours Standard Deviation 0.895

Adverse Events

Antizol 1.0 mg/kg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Antizol 3.0 mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Antizol 5.0 mg/kg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Overall

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Antizol 1.0 mg/kg n=16 participants at risk Participants received alternating study treatment (oral Antizol 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.	Antizol 3.0 mg/kg n=8 participants at risk Participants received alternating study treatment (oral Antizol 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.	Antizol 5.0 mg/kg n=8 participants at risk Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.	Pooled Placebo n=32 participants at risk Participants received placebo on either Study Day 1 or Study Day 2), administered 30 minutes prior to ethanol.	Overall n=32 participants at risk Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
Nervous system disorders Headache	31.2% 5/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	37.5% 3/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	21.9% 7/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	46.9% 15/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Nervous system disorders Dysgeusia	50.0% 8/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	25.0% 8/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Nervous system disorders Dizziness	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	6.2% 2/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	9.4% 3/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Investigations Blood pressure diastolic increased	18.8% 3/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	25.0% 2/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	6.2% 2/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	18.8% 6/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Investigations Blood pressure systolic decreased	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	25.0% 2/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	9.4% 3/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	18.8% 6/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Investigations Respiratory rate increased	37.5% 6/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	62.5% 5/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	15.6% 5/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	46.9% 15/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Investigations Blood pressure systolic increased	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	3.1% 1/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	6.2% 2/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Cardiac disorders Tachycardia	12.5% 2/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	25.0% 2/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	25.0% 8/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	34.4% 11/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Cardiac disorders Bradycardia	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	6.2% 2/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Gastrointestinal disorders Nausea	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	18.8% 6/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	21.9% 7/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Gastrointestinal disorders Vomiting	0.00% 0/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	15.6% 5/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	18.8% 6/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Investigations Blood LDH increased	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	3.1% 1/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	6.2% 2/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Investigations Blood triglycerides increased	0.00% 0/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	12.5% 1/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	3.1% 1/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	6.2% 2/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Nervous system disorders Lethargy	6.2% 1/16 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/8 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	0.00% 0/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit	3.1% 1/32 • Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit

Additional Information

Beth Robinson, Executive Director

Horizon Pharma USA, Inc.

Email: clinicaltrials@horizonpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Horizon requests that any Investigator/institution that plans on presenting or publishing results provide written notification of their request a minimum of 60 days prior to presentation or publication. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsors' Intellectual Property rights .
• Publication restrictions are in place

Restriction type: OTHER