NCT05106309

Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy Participants

A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations Under Fasted and Fed Conditions in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A 2-part, crossover design, open-label treatment trial with 4 periods, 4 sequences (Part A) to evaluate MR formulations of CVL-231 and a 2 periods, 2 sequences (Part B) to understand effect of food on CVL-231 exposures from an MR formulation.

Detailed description

CVL-231 is a muscarinic acetylcholine receptor (mAChR) activator that selectively binds to the M4 muscarinic receptor subtype (M4 mAChR) and is being developed for treatment of psychosis in schizophrenia. Part A of this 2-part trial will investigate the PK of CVL-231 in healthy participants following a single oral dose of CVL-231 as 3 modified-release (MR) formulations with different release rates and an immediate-release (IR) formulation under fasted conditions. Upon selection of an MR formulation with appropriate PK characteristics, the effect of food on the PK of CVL-231 and its metabolite following single oral doses of the selected MR formulation may be evaluated in Part B.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	10 mg CVL-231 as IR formulation	Tablets
DRUG	30 mg CVL-231 as slow-release MR formulation	Capsules
DRUG	30 mg CVL-231 as medium release MR formulation	Capsules
DRUG	30 mg CVL-231 as fast release MR formulation	Capsules
DRUG	30 mg CVL-231 Target Release, Fasted	Capsules
DRUG	30 mg CVL-231 Target Release, Fed	Capsules

Timeline

• Start date: 2021-12-29
• Primary completion: 2022-02-24
• Completion: 2022-02-24
• First posted: 2021-11-03
• Last updated: 2022-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study