Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.
Approximately 32 subjects will be enrolled in ascending dosing cohorts of 8 subjects each. Each subject will receive an oral dose of study drug (fomepizole or placebo) with concomitant ethanol with group assignment in a randomized 1:1:1:1 ratio (2 subjects each group) on Study Day 1. Each subject is their own intra-subject control with the alternative study drug (fomepizole or placebo) administered on the next day (Study Day 2). Four subjects in each cohort will receive study drug (fomepizole or placebo) administered 30 minutes prior to ethanol, 4 with study drug (fomepizole or placebo) administered 30 minutes after ethanol. The study will assess safety and tolerability of fomepizole and the PK/PD of 4-MP, ethanol and acetaldehyde in the subject population.
Study with completed results acquired from Horizon in 2024.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Antizol 1.0 mg/kg | Experimental | Participants receive alternating study treatment (oral fomepizole 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. |
|
| Cohort 2: Antizol 3.0 mg/kg | Experimental | Participants receive alternating study treatment (oral fomepizole 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. |
|
| Cohort 3: Antizol 5.0 mg/kg | Experimental | Participants receive alternating study treatment (oral fomepizole 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. |
|
| Cohort 4: Antizol 1.0 mg/kg | Experimental | Participants receive alternating study treatment (oral fomepizole 7.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antizol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | 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. | Study Day 0 through Study Visit Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| PK of 4-MP: Dose-Normalized (DN) Cmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Vaccination within 2 weeks of Day 1
Current respiratory disease or a past history of chronic respiratory disease, or current smoker within last six months
Any one of the following Screening ECG findings:
History or evidence of drug or alcohol abuse or regular consumption of more than 8 units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from non study alcohol during the 36 hours prior to dose administration and until completion of blood sampling on Day 7
Subjects who have donated blood totalling more than 550 mL within the 3 months prior to Day 1
Use of any prescription medication other than oral contraceptives during the 14 days prior to Day 1, unless approved by both the Principal Investigator (PI) and the Sponsor
Inability to abstain from smoking any tobacco product from within prior to 2 hours of blood sampling to after 2 hours of blood sampling during the study period.
Use of any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to Day 1 unless approved by both the PI and the Sponsor
Chronic use of pain medications
Administration of an investigational agent within the last 30 days (or within a period of less than 5 times the agent's half-life, whichever is longer) prior to Day 1
Major surgery within 60 days prior to Day 1, or any planned surgery or medical procedure during the study period (through Day 7)
Positive alcohol breath-test or Positive drug screen (e.g., opiates, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamines) during screening or at Day 0 Check-In
Known hypersensitivity reaction to Antizol® or other pyrazoles, tomato juice
Abnormal laboratory results, including:
Any other clinically significant abnormal result for hematology, clinical chemistry, or urinalysis at screening or check-In
Positive serum pregnancy test for females of childbearing potential
Subject and/or partner unable or unwilling to use an effective form of barrier contraceptives during the course of the study and for 7 days after study drug administration.
Cancer (excluding adequately treated basal cell carcinoma) within the last 5 years
Significant past medical history of hepatic, renal, cardiovascular (including family history of prolonged QT syndrome), pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic endocrine or other diseases; or any condition that in the opinion of the Investigator would complicate or compromise the study, or the well-being of the subject
Any other reason, which in the opinion of the Principal Investigator, would prevent the subject from completing or following the study schedule
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Honolulu CRU | Honolulu | Hawaii | 96813 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6377951 | Background | Inoue K, Fukunaga M, Kiriyama T, Komura S. Accumulation of acetaldehyde in alcohol-sensitive Japanese: relation to ethanol and acetaldehyde oxidizing capacity. Alcohol Clin Exp Res. 1984 May-Jun;8(3):319-22. doi: 10.1111/j.1530-0277.1984.tb05519.x. | |
| 4021229 | Background | Inoue K, Kera Y, Kiriyama T, Komura S. Suppression of acetaldehyde accumulation by 4-methylpyrazole in alcohol-hypersensitive Japanese. Jpn J Pharmacol. 1985 May;38(1):43-8. doi: 10.1254/jjp.38.43. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Antizol 1.0 mg/kg and Placebo | 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. |
| BG001 | Antizol 3.0 mg/kg and Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | 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. | Posted | Count of Participants | Participants | Study Day 0 through Study Visit Day 7 |
|
Adverse events were recorded from Check-In (Study Day 0) through Study Visit Day 7/Study End Visit
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antizol 1.0 mg/kg | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Robinson, Executive Director | Horizon Pharma USA, Inc. | clinicaltrials@horizonpharma.com |
Not provided
| ID | Term |
|---|---|
| D000077604 | Fomepizole |
| C077079 | 4-methylpiperazine-2,6-dione |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| Ethanol | Other | oral dose of ethanol (0.5 g/kg) |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| PK of 4-MP: Apparent Clearance (CL/F) | 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 |
| PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F) | 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: 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 |
| PK of Ethanol: CL/F | 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 |
| PK of Ethanol: Vz/F | 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| PK of Acetaldehyde: 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 |
| 15204767 | Background | Tardif R, Liu L, Raizenne M. Exhaled ethanol and acetaldehyde in human subjects exposed to low levels of ethanol. Inhal Toxicol. 2004 Apr;16(4):203-7. doi: 10.1080/08958370490277272. |
| 14652286 | Background | Yokoyama T, Yokoyama A, Kato H, Tsujinaka T, Muto M, Omori T, Haneda T, Kumagai Y, Igaki H, Yokoyama M, Watanabe H, Yoshimizu H. Alcohol flushing, alcohol and aldehyde dehydrogenase genotypes, and risk for esophageal squamous cell carcinoma in Japanese men. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1227-33. |
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. |
| BG002 | Antizol 5.0 mg/kg and Placebo | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Antizol 1.0 mg/kg |
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. |
| OG001 | Antizol 3.0 mg/kg | 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. |
| OG002 | Antizol 5.0 mg/kg | 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. |
| OG003 | Pooled Placebo | Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol. |
| OG004 | Overall | 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. |
|
|
| Secondary | Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | ng/mL | 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 | Posted | Mean | Standard Deviation | (ng/mL)/mg | 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) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Median | Full Range | hours | 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]) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | ng*hr/mL | 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) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | (ng*hr/mL)/mg | 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-∞]) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | ng*hr/mL | 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-∞) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | (ng*hr/mL)/mg | 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) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | percentage | 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) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | hours | 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: Apparent Clearance (CL/F) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | L/hr | 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: Apparent Volume of Distribution During Terminal Phase (Vz/F) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | Liters | 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 Ethanol: Cmax | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | mg/dL | 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 Ethanol: DN Cmax | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | (mg/dL)/mg | 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 Ethanol: Tmax | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Median | Full Range | hours | 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 Ethanol: AUC(0-t) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | mg*hr/dL | 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 Ethanol: DN AUC(0-t) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | (mg*hr/dL)/mg | 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 Ethanol: AUC(0-∞) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | mg*hr/mL | 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 Ethanol: DN AUC(0-∞) | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | (mg*hr/dL)/mg | 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 Ethanol: AUC%Extrap | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | percentage | 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 Ethanol: T1/2 | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | hours | 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 Ethanol: CL/F | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | dL/hr | 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 Ethanol: Vz/F | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Posted | Mean | Standard Deviation | dL | 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 Acetaldehyde: Cmax | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | µM | 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 Acetaldehyde: DN Cmax | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | µM/mg | 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 Acetaldehyde: Tmax | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Median | Full Range | hours | 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 Acetaldehyde: AUC(0-t) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | µM*hr | 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 Acetaldehyde: DN AUC(0-t) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | µM*hr/mg | 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 Acetaldehyde: AUC(0-∞) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | µM*hr | 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 Acetaldehyde: DN AUC(0-∞) | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | µM*hr/mg | 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 Acetaldehyde: AUC%Extrap | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | percentage | 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 Acetaldehyde: T1/2 | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | Posted | Mean | Standard Deviation | hours | 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 |
|
|
|
| 0 |
| 16 |
| 13 |
| 16 |
| EG001 | Antizol 3.0 mg/kg | 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. | 0 | 8 | 6 | 8 |
| EG002 | Antizol 5.0 mg/kg | 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. | 0 | 8 | 8 | 8 |
| EG003 | Pooled Placebo | Participants received placebo on either Study Day 1 or Study Day 2), administered 30 minutes prior to ethanol. | 0 | 32 | 21 | 32 |
| EG004 | Overall | 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. | 0 | 32 | 28 | 32 |
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | Systematic Assessment |
|
| Blood pressure systolic decreased | Investigations | Systematic Assessment |
|
| Respiratory rate increased | Investigations | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Blood LDH increased | Investigations | Systematic Assessment | lactic acid dehydrogenase (LDH) |
|
| Blood triglycerides increased | Investigations | Systematic Assessment |
|
| Lethargy | Nervous system disorders | Systematic Assessment |
|
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 .
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
1.0 mg/kg Cohort, 3.0 mg/kg cohort
| ANOVA |
| 0.386 |
P-values for pairwise comparison between cohorts from ANOVA |
| Superiority |
| 1.0 mg/kg, 5.0 mg/kg | ANOVA | 0.0006 | P-values for pairwise comparison between cohorts from ANOVA | Superiority |
| 3.0 mg/kg, 5.0 mg/kg | ANOVA | 0.0154 | P-values for pairwise comparison between cohorts from ANOVA | Superiority |
| ratio of parameter means |
| 126.05 |
| 2-Sided |
| 90 |
| 101.94 |
| 155.87 |
Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. |
| Superiority |
| ratio of parameter means | 137.58 | 2-Sided | 90 | 115.66 | 163.65 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means | 82.4 | 2-Sided | 90 | 62.83 | 108.07 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| 3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included. | ratio of parameter means | 115.25 | 2-Sided | 90 | 91.19 | 145.67 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| Analyses for Cohort 3 where all available data were included. | ratio of parameter means | 112.64 | 2-Sided | 90 | 96.14 | 131.98 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means |
| 120.76 |
| 2-Sided |
| 90 |
| 108.80 |
| 134.03 |
Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. |
| Superiority |
| ratio of parameter means | 143.39 | 2-Sided | 90 | 107.72 | 190.87 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means | 103.13 | 2-Sided | 90 | 84.35 | 126.10 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| 3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included. | ratio of parameter means | 123.17 | 2-Sided | 90 | 108.61 | 139.67 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| Analyses for Cohort 3 where all available data were included. | ratio of parameter means | 137.17 | 2-Sided | 90 | 123.30 | 152.59 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means |
| 123.7 |
| 2-Sided |
| 90 |
| 93.55 |
| 163.56 |
Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. |
| Superiority |
| ratio of parameter means | 150.33 | 2-Sided | 90 | 93.14 | 242.63 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| Analysis for Cohort 3 where all available data were included. | ratio of parameter means | 122.83 | 2-Sided | 90 | 82.45 | 183.00 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means |
| 124.46 |
| 2-Sided |
| 90 |
| 88.77 |
| 174.50 |
Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. |
| Superiority |
| ratio of parameter means | 105.31 | 2-Sided | 90 | 89.24 | 124.27 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means | 88.6 | 2-Sided | 90 | 56.66 | 138.54 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| 3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included. | ratio of parameter means | 70.77 | 2-Sided | 90 | 34.16 | 146.59 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| Analyses for Cohort 3 where all available data were included. | ratio of parameter means | 86.04 | 2-Sided | 90 | 55.78 | 132.73 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means |
| 112.28 |
| 2-Sided |
| 90 |
| 103.72 |
| 121.54 |
Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. |
| Superiority |
| ratio of parameter means | 106.08 | 2-Sided | 90 | 96.81 | 116.24 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| ratio of parameter means | 104.12 | 2-Sided | 90 | 83.50 | 129.84 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| 3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included. | ratio of parameter means | 100.41 | 2-Sided | 90 | 77.86 | 129.49 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
| Analyses for Cohort 3 where all available data were included. | ratio of parameter means | 94.7 | 2-Sided | 90 | 82.70 | 108.42 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |
3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.
| ratio of parameter means |
| 107.05 |
| 2-Sided |
| 90 |
| 87.42 |
| 131.10 |
Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. |
| Superiority |
| Analyses for Cohort 3 where all available data were included. | ratio of parameter means | 97.9 | 2-Sided | 90 | 84.84 | 112.97 | Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale. | Superiority |