NCT05935033

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine

A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics and Safety Following a Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Hepatic Impairment Compared With Adult Participants With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic impairment relative to matched participants with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Emraclidine	Tablet

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-02-21
• Completion: 2025-02-21
• First posted: 2023-07-07
• Last updated: 2025-04-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study