NCT04592536

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

A Randomized, Double-blind, Placebo- and Active Comparator-controlled, Crossover Trial to Examine the Effect of Multiple Doses of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subject

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-11-14
• Completion: 2021-12-13
• First posted: 2020-10-19
• Last updated: 2022-01-11

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study