NCT03203499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2017

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

June 28, 2017

Last Update Submit

January 12, 2018

Conditions

Healthy Volunteers

Keywords

Substance abuse disorder

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events

    Up to 36 hours postdose

Secondary Outcomes (5)

  • 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

Study Arms (2)

ANS-6637

EXPERIMENTAL

Single ascending doses of ANS-6637 administered orally

Drug: ANS-6637 Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo Oral Tablet

Interventions

ANS-6637 Oral TabletDRUG

Ascending single doses administered orally.

ANS-6637
Placebo Oral TabletDRUG

Placebo administered orally.

Placebo

Eligibility Criteria

Age21 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy male moderate drinkers.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male adults, between 21 and 45 years of age, inclusive.
  • Body mass index (BMI) within 19.0 to 34.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at screening).
  • Resting semisupine vital signs at screening and each clinic admission within the following ranges:
  • Systolic blood pressure 90 to 140 mmHg
  • Diastolic blood pressure of 50 to 90 mmHg
  • Heart rate of 40 to 90 beats per minute (bpm)
  • 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.

You may not qualify if:

  • 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).
  • Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vince and Associates

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

ANS-6637

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Debra Kelsh, MD

    Vince and Associates

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

February 27, 2017

Primary Completion

November 15, 2017

Study Completion

November 15, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)