Drug: CVL-354 for Depression

Phase 1

Waitlist Available

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 29 days following last dose with imp

Summary

This trial tests a new drug called CVL-354 in humans for the first time. It aims to find out how safe it is and what the right dose should be. The study likely involves healthy volunteers to understand how the drug works in the body.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 29 days following last dose with imp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 29 days following last dose with imp

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days following last dose with imp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Part A&B: Changes in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)

Primary Part A&B: Incidence and severity of Treatment -Emergent Adverse Events (TEAEs)

Primary Part A&B: Incidence of clinically significant changes in vital sign measurements

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single Ascending Dose (SAD) Cohorts 1-3Experimental Treatment2 Interventions

In Cohorts 1 and 2, all participants will receive treatment with up to 3 single oral doses of CVL-354 and/or 1 single oral dose of placebo in a 4-period crossover design. The starting dose of CVL-354 will be 0.5 mg. Participants will be randomized to 1 of 4 treatment sequences. Cohort 3 may be used to evaluate additional doses or evaluate food effect, depending on the results from Cohorts 1 and 2.

Group II: Multiple Ascending Dose (MAD) Cohorts 1-5Experimental Treatment2 Interventions

All participants will receive treatment with multiple oral doses of CVL-354 (dose and regimen to be determined) or matching placebo for 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Drug: CVL-354

2021

Completed Phase 1

~80

Drug: Placebo

2013