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

Phase 1 Completed 73 enrolled Cerevel Therapeutics, LLC National Institute on Drug Abuse (NIDA) · collab

RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start: 2021-10-18
Primary completion: 2023-01-23
Completion: 2023-01-23

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icalcaprant	Unknown	0.5 mg	Oral
Subject	Icalcaprant	Unknown	1.5 mg	Oral
Subject	Icalcaprant	Unknown	5 mg	Oral
Subject	Icalcaprant	Unknown	10 mg	Oral
Subject	Icalcaprant	Unknown	15 mg	Oral
Subject	Icalcaprant	Unknown	25 mg	Oral
Subject	Icalcaprant	Unknown	45 mg	Oral
Subject	Icalcaprant	Unknown	50 mg	Oral
Subject	Icalcaprant	Unknown	80 mg	Oral
Subject	Icalcaprant	Unknown	85 mg	Oral
Subject	Icalcaprant	Unknown	90 mg	Oral
Subject	Icalcaprant	Unknown	150 mg	Oral
Subject	Icalcaprant	Unknown	200 mg	Oral

Indications

No indication recorded.