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

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

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

Study Overview

• Status: Completed
• Conditions: Ethanol Intoxication
• Intervention / Treatment: Drug: ADX-629; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45230
      • Medpace Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 3 oral doses of placebo
Experimental: ADX-629 Oral Tablets	Drug: ADX-629; 3 oral doses of ADX-629 600 milligrams

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Serious Adverse Events	Safety was assessed through serious adverse event collection.	The safety assessment period was approximately two days for each treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of Dermal Flushing	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.	The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Change From Baseline for Romberg Test	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.	The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): May 29, 2022
• Study Completion (Actual): May 29, 2022

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Aldeyra; ADX-629
• Other Study ID Numbers: ADX-629-ET-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No