Dosing Starts in Pharmacokinetics Study of AD04 for Alcohol Use Disorder
The first patient in a pharmacokinetics study of AD04 (0.33 mg ondansetron) for the treatment of alcohol use disorder has been dosed, biopharmaceutical company Adial Pharmaceuticals recently announced.
The study, which is expected to take 6 months to complete, satisfies a requirement of US Food and Drug Administration (FDA) guidance for an upcoming phase 3 trial of AD04. The investigational therapeutic agent is a genetically targeted, serotonin-3 receptor antagonist for the treatment of alcohol use disorder in patients who drink less than 10 drinks per drinking day. AD04 is thought to reduce alcohol craving.
The single-center, open-label study will enroll up to 30 healthy adult volunteers. Researchers will compare the pharmacokinetic profile of oral AD04 twice daily with or without food against a reference standard product.
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The findings are expected to provide information on the pharmacokinetic properties of AD04. Adial Pharmaceuticals plans to share topline results from the study early in the fourth quarter of 2024.
“Looking ahead, we plan to engage with the FDA in Q4 2024 to discuss the results of this pharmacokinetics study and obtain feedback to refine the phase 3 study design,” said Cary Claiborne, president and chief executive officer of Adial Pharmaceuticals. “This meeting will help establish the final protocol and ensure that it aligns with FDA expectations, further advancing AD04 towards regulatory approval.”
A companion diagnostic genetic test to identify specific genotypes that may benefit from AD04 will be used in upcoming studies.
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