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

NCT ID: NCT03203499

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2017-11-15

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ANS-6637

Single ascending doses of ANS-6637 administered orally

Group Type: EXPERIMENTAL

ANS-6637 Oral Tablet

Intervention Type: DRUG

Ascending single doses administered orally.

Placebo

Placebo administered orally

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo administered orally.

Interventions

ANS-6637 Oral Tablet

Ascending single doses administered orally.

Intervention Type: DRUG

Placebo Oral Tablet

Placebo administered orally.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Amygdala Neurosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Kelsh, MD

Role: STUDY_DIRECTOR

Vince and Associates

Locations

Vince and Associates

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

ANS-A-C1-001

Identifier Type: -

Identifier Source: org_study_id