NCT05138653

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

A Phase 1, Double-blind (Investigator and Participant), First-in-Human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CVL-354 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	CVL-354	Oral solution/suspension
DRUG	Placebo	Placebo matched to CVL-354
DRUG	CVL-354	Capsule

Timeline

• Start date: 2021-10-18
• Primary completion: 2023-01-23
• Completion: 2023-01-23
• First posted: 2021-12-01
• Last updated: 2024-11-26
• Results posted: 2024-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study