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

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

October 27, 2023

Study Completion Date

October 27, 2023

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.

Trial Locations (1)

77030

Michael E. DeBakey Veterans Affairs Medical Center, Houston

All Listed Sponsors
collaborator

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

OTHER

collaborator

Congressionally Directed Medical Research Programs

FED

collaborator

Michael E. DeBakey VA Medical Center

FED

collaborator

Baylor College of Medicine

OTHER

lead

Pop Test Oncology LLC

INDUSTRY

NCT04331288 - Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study) | Biotech Hunter | Biotech Hunter