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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ethanol Intoxication

Treatments: Drug: ADX-629; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05487404

ADX-629-ET-001

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

ADX-629 Oral Tablets

Experimental group

Treatment:

Drug: ADX-629

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo