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

Phase 1

Completed

• Conditions: Ethanol Intoxication
• Interventions: Drug: Placebo; Drug: ADX-629

• Registration Number: NCT05487404
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Primary Completion: 2022-05-29
• Study Completion: 2022-05-29
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ADX-629 Oral Tablets	ADX-629	-

Primary Outcome Measures

Name	Time	Method
Assessment of symptoms using the Global Impression Visual Analog Scale	In the two days of each Cycle (each cycle is 2 days)	Score from 0 to 100 with "0" being no symptoms and "100" being maximal symptoms

Secondary Outcome Measures

Name	Time	Method
Assessment of symptoms using the Clinical Global Impression - Impairment Severity Scale	In the two days of each Cycle (each cycle is 2 days)	Score from 0 to 7: 1 = no impairment and 7 = very severe impairment
Assessment of symptoms using the Alcohol Toxicity Symptom Scale	In the two days of each Cycle (each cycle is 2 days)	Score from 0 to 10 with "0" being not present/least severe and "10" being most severe

Trial Locations

Locations (1)

Medpace Clinical Pharmacology; 🇺🇸 Cincinnati, Ohio, United States