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Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)

NCT04331288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-12-04

No results posted yet for this study

Summary

The purpose of this clinical study is to assess pharmacokinetic interactions between ethanol (EtOH) and PT150 (900 mg qd) in non-treatment-seeking alcohol-experienced volunteers-(to include military service members, veterans and/or civilians).

Conditions

  • Potential Treatment for Alcohol Dependence-Alcohol Interaction

Interventions

DRUG

PT150

Intervention 1 includes PT150 with alcohol consumption

OTHER

Beverage

The 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 juice or another flavored beverage. Participants will be allowed 30 minutes to consume the beverages.

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

  • Pop Test Oncology LLC

    lead INDUSTRY

Principal Investigators

  • Christopher Verrico, PhD · Michael E. DeBakey Veterans Affairs Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-10-27
Completion
2023-10-27
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 NCT04331288 on ClinicalTrials.gov