A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol

Study Overview
=================
Brief Summary
-----------------
This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a screening visit, a qualification visit, a Treatment Phase and follow-up.

Official Title
-----------------
A Phase 1b, Proof of Concept, Dose-Ranging Study to Evaluate the Safety of the Coadministration of Ascending Doses of ANS-6637 and Ethanol in Healthy Male Moderate Drinkers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ANS-6637 Oral Tablet
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male adults, between 21 and 45 years of age, inclusive. Body mass index (BMI) within 19.0 to 34.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at screening). Resting semisupine vital signs at screening and each clinic admission within the following ranges: Systolic blood pressure 90 to 140 mmHg Diastolic blood pressure of 50 to 90 mmHg Heart rate of 40 to 90 beats per minute (bpm) Current alcohol users who are self-reported moderate drinkers, defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least 1 occasion in the 30 days prior to screening. One standard alcoholic drink (14 grams of EtOH) is equivalent to 43 mL (1.5 oz) hard liquor, 142 mL (5 oz) wine or 341 mL (12 oz) beer. Exclusion Criteria: Drug or alcohol dependence within the 12 months prior to screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR), or any self-reported dependence or addiction within the subject's lifetime (except nicotine or caffeine). Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation). Current or prior diagnosis of any condition where alcohol consumption is contraindicated, including, but not limited to, hypertriglyceridemia, pancreatitis, liver disease, porphyria, and/or congestive heart failure, that is clinically relevant, as judged by the investigator or designee. Positive urine drug test for EtOH, cocaine, oxycodone and other opioids, amphetamines, benzodiazepines and/or cannabinoids at clinic admission. Positive results may be repeated and/or subjects rescheduled at the investigator's or designee's discretion.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANS-6637<br>Single ascending doses of ANS-6637 administered orally | Drug: ANS-6637 Oral Tablet<br>* Ascending single doses administered orally.<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally | Drug: Placebo Oral Tablet<br>* Placebo administered orally.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | Up to 36 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Up to 48 hours postdose | 
| Time to maximum observed serum concentration (Tmax) |  | Up to 48 hours postdose | 
| Areas under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast) |  | Up to 48 hours postdose | 
| Ethanol Consumption |  | Up to 6 hours postdose | 
| Modified 5-Item Drug Effects Questionnaire (mDEQ-5) |  | Up to 6 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance abuse disorder