Healthy Volunteers
Conditions
Keywords
Substance abuse disorder
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.
Interventions
DRUGANS-6637 Oral Tablet
Ascending single doses administered orally.
DRUGPlacebo Oral Tablet
Placebo administered orally.
Sponsors
Amygdala Neurosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events | Up to 36 hours postdose |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed