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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-05-29

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

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Detailed Description

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Conditions

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Ethanol Intoxication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ADX-629 Oral Tablets

Group Type EXPERIMENTAL

ADX-629

Intervention Type DRUG

3 oral doses of ADX-629 600 milligrams

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 oral doses of placebo

Interventions

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ADX-629

3 oral doses of ADX-629 600 milligrams

Intervention Type DRUG

Placebo

3 oral doses of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;
2. Subjects with the ability to obtain transportation to and from the study site;
3. Subjects who agree to abstain from consumption of non-study alcohol during the study.

Exclusion Criteria

1. Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;
2. Subjects with nicotine product use within 14 days prior to Screening until the end of the study;
3. 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;
4. Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No