MedTrace Logo

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

NCT05106309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-04-27

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

10 mg CVL-231 as IR formulation

Tablets

DRUG

30 mg CVL-231 as slow-release MR formulation

Capsules

Sponsors & Collaborators

  • Cerevel Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Matthew Leoni, MD, MBA · Cerevel Therapeutics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2022-02-24
Completion
2022-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05106309 on ClinicalTrials.gov