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A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants

NCT05138653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-11-26

Study results available
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Summary

This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.

Conditions

  • Healthy Participants

Interventions

DRUG

CVL-354

Oral solution/suspension

DRUG

Placebo

Placebo matched to CVL-354

DRUG

CVL-354

Capsule

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Cerevel Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2023-01-23
Completion
2023-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05138653 on ClinicalTrials.gov