Clinical trial NCT03203499: A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Substance abuse disorder
Lead sponsor: Amygdala Neurosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 48
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: Up to 36 hours postdose
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 48 hours postdose
measure: Time to maximum observed serum concentration (Tmax)
timeFrame: Up to 48 hours postdose
measure: Areas under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
timeFrame: Up to 48 hours postdose
measure: Ethanol Consumption
timeFrame: Up to 6 hours postdose
measure: Modified 5-Item Drug Effects Questionnaire (mDEQ-5)
timeFrame: Up to 6 hours postdose
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates
state: Kansas
Study officials:
affiliation: Vince and Associates
name: Debra Kelsh, MD
role: STUDY_DIRECTOR
References: