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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Ethanol Intoxication

In brief

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

Key facts

Study ID

NCT05487404

Run by

Aldeyra Therapeutics, Inc.

People needed

26

Starts

2021-11-15

Expected to finish

2022-05-29

Last updated by the study team

2025-02-28

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Medpace Clinical Pharmacology — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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