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

NCT05487404 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ADX-629-ET-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ethanol Intoxication

Keywords

Aldeyra; ADX-629

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline of Dermal Flushing

  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

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

Study Arms (2)

ADX-629 Oral Tablets

EXPERIMENTAL

Drug: ADX-629

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ADX-629 DRUG

3 oral doses of ADX-629 600 milligrams

ADX-629 Oral Tablets

Placebo DRUG

3 oral doses of placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45230, United States

Location

MeSH Terms

Interventions

ADX-629

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: November 15, 2021
• Primary Completion: May 29, 2022
• Study Completion: May 29, 2022
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)