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

Phase 1

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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).

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.