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Completed

NCT Number: NCT05487404

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

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

Completed

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Key information

Conditions

Ethanol Intoxication

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45230, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ADX-629

Drug

3 oral doses of ADX-629 600 milligrams

Placebo

Drug

3 oral doses of placebo

Primary outcomes

  1. Number of Subjects With Serious Adverse Events

    Time frame: The safety assessment period was approximately two days for each treatment period.

    Safety was assessed through serious adverse event collection.

Secondary outcomes

  1. Change From Baseline of Dermal Flushing

    Time frame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.

    Dermal flushing was assessed on a 0 to 100 scale (0 = none, 100 = extremely severe). Change from baseline was analyzed using mixed model for repeated measures (MMRM), with baseline and emesis volume as covariates, and sequence, period, time point, and treatment as factors.

  2. Change From Baseline for Romberg Test

    Time frame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.

    Romberg Test was assessed for up to 60 seconds. Subjects stood with feet together and eyes closed, and the length of time the subject was able to stand without movement was recorded. Change from baseline was analyzed using MMRM, with baseline, number of bodyweight-standardized drinks consumed, and blood alcohol concentration as covariates, and sequence, period, time point, treatment, and the interaction of treatment by time point as factors.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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