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

Aldeyra Therapeutics, Inc.26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ethanol Intoxication

Interventions

ADX-629DRUG

3 oral doses of ADX-629 600 milligrams

PlaceboDRUG

3 oral doses of placebo

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Number of Subjects With Serious Adverse Events

Safety was assessed through serious adverse event collection.

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

Secondary Outcomes

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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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