A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels

Study Overview
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Brief Summary
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A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels

Official Title
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A Double-Blind Clinical Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels

Conditions
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Ethanol Intoxication

Intervention / Treatment
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* Drug: ADX-629
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening; Subjects with the ability to obtain transportation to and from the study site; Subjects who agree to abstain from consumption of non-study alcohol during the study. Exclusion Criteria: Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening; Subjects with nicotine product use within 14 days prior to Screening until the end of the study; Subjects with any history of or current alcohol or other substance use disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-629 Oral Tablets<br> | Drug: ADX-629<br>* 3 oral doses of ADX-629 600 milligrams<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3 oral doses of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of symptoms using the Global Impression Visual Analog Scale | Score from 0 to 100 with 0 being no symptoms and 100 being maximal symptoms | In the two days of each Cycle (each cycle is 2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of symptoms using the Clinical Global Impression - Impairment Severity Scale | Score from 0 to 7: 1 = no impairment and 7 = very severe impairment | In the two days of each Cycle (each cycle is 2 days) | 
| Assessment of symptoms using the Alcohol Toxicity Symptom Scale | Score from 0 to 10 with 0 being not present/least severe and 10 being most severe | In the two days of each Cycle (each cycle is 2 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aldeyra, ADX-629