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

• Sponsor: Aldeyra Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05487404
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ethanol Intoxication	Drug: ADX-629; Drug: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Nov 15, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medpace Clinical Pharmacology	Cincinnati	Ohio	United States	45230

Sponsors and Collaborators

• Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aldeyra Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05487404
• Other Study ID Numbers: ADX-629-ET-001
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aldeyra Therapeutics, Inc.: Aldeyra; ADX-629

Study Results

No Results Posted as of Aug 4, 2022