NCT06719908

A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers

A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Afasci Inc · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol. Participants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.

Detailed description

This is a randomized, double-blind, placebo-controlled, 4-way crossover study of the interaction of alcohol and oral AFA-281 in healthy adult volunteers. This study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of co-administration of AFA-281 and ethanol in healthy, male and female subjects who are social or moderate drinkers but do not meet criteria for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Alcohol Use Disorder. Each subject will receive single doses of AFA-281, ethanol, placebo for AFA-481, and placebo for ethanol in a randomized, double-blind, crossover manner. Randomized blocks will be included to ensure that there is 1 day in between treatment sessions. Blood will be collected for PK and blood alcohol levels at pre-dose and at multiple timepoints after treatment. Safety parameters will be evaluated for tolerability such as vital signs and clinical pathology. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.

Conditions

• Alcohol
• Alcohol Use Disorders

Interventions

Type	Name	Description
DRUG	AFA-281 is a small molecule, orally available	This is a study to evaluate the interaction of AFA-281 with alcohol
OTHER	Alcohol (Ethanol)	Alcohol will be administered in combination with AFA-281 or AFA-281 placebo

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2029-09-01
• First posted: 2024-12-06
• Last updated: 2024-12-06

Regulatory

• FDA-regulated drug study