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A Trial of the Effect of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subjects

NCT04592536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-01-11

No results posted yet for this study

Summary

The purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865 using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy volunteers.

Conditions

  • Panic Disorder

Interventions

DRUG

CVL-865 High dose

High dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day)

DRUG

Alprazolam 1mg XR

Alprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day)

DRUG

Placebo

Placebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day)

DRUG

CVL-865 low dose

Low dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)

Sponsors & Collaborators

  • Cerevel Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Gabriel Etienne Jacobs, PhD, MD · Centre for Human Drug Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2021-11-14
Completion
2021-12-13
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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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 NCT04592536 on ClinicalTrials.gov