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

NCT03203499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-01-17

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ANS-6637 Oral Tablet

Ascending single doses administered orally.

DRUG

Placebo Oral Tablet

Placebo administered orally.

Sponsors & Collaborators

  • Amygdala Neurosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Debra Kelsh, MD · Vince and Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2017-11-15
Completion
2017-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03203499 on ClinicalTrials.gov