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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203499
• Other study ID #: ANS-A-C1-001
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2017
• Last updated: January 12, 2018
• Start date: February 27, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: January 2018
• Source: Amygdala Neurosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ANS-6637 Oral Tablet
Ascending single doses administered orally.
• Placebo Oral Tablet
Placebo administered orally.

Locations

Country	Name	City	State
United States	Vince and Associates	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Amygdala Neurosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		Up to 36 hours postdose
Secondary	Maximum observed serum concentration (Cmax)		Up to 48 hours postdose
Secondary	Time to maximum observed serum concentration (Tmax)		Up to 48 hours postdose
Secondary	Areas under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)		Up to 48 hours postdose
Secondary	Ethanol Consumption		Up to 6 hours postdose
Secondary	Modified 5-Item Drug Effects Questionnaire (mDEQ-5)		Up to 6 hours postdose