NCT06301971

A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants

A Phase 1, Open-Label Trial to Assess the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of \[14C\]-emraclidine in healthy adult male participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Emraclidine	Oral solution/suspension

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2024-03-08
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study