NCT05940402

A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function

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 Renal Impairment Compared With Adult Participants With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (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 renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Emraclidine	Oral tablets

Timeline

• Start date: 2023-07-24
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2023-07-11
• Last updated: 2025-04-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study