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

Amygdala Neurosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo Oral Tablet; Drug: ANS-6637 Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03203499

ANS-A-C1-001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male adults, between 21 and 45 years of age, inclusive.

2. Body mass index (BMI) within 19.0 to 34.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at screening).

3. Resting semisupine vital signs at screening and each clinic admission within the following ranges:

   1. Systolic blood pressure 90 to 140 mmHg
   2. Diastolic blood pressure of 50 to 90 mmHg
   3. Heart rate of 40 to 90 beats per minute (bpm)

4. 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

1. 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).
2. Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
3. 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.
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

ANS-6637

Experimental group

Description:

Single ascending doses of ANS-6637 administered orally

Treatment:

Drug: ANS-6637 Oral Tablet

Placebo

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo Oral Tablet