A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 21 - 45 |
Updated: | 1/19/2018 |
Start Date: | February 27, 2017 |
End Date: | November 15, 2017 |
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
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.
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.
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.
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