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Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

NCT03548714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-22

No results posted yet for this study

Summary

The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study drug) treatment.

Conditions

  • Alcohol Dependence
  • Alcohol Interaction

Interventions

DRUG

PT150

Intervention 1 includes PT150 with alcohol consumption

OTHER

Beverage

Alcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in grape Kool-Aid (Kraft Foods, Northfield, IL). Placebo will be prepared in the same manner but contain 1% alcohol to mask taste.

Sponsors & Collaborators

  • Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

    collaborator OTHER

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Baylor College of Medicine

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Pop Test Oncology LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-07-15
Completion
2019-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03548714 on ClinicalTrials.gov