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	Small molecule	0.5 mg	Oral
Subject	Icalcaprant	Small molecule	1.5 mg	Oral
Subject	Icalcaprant	Small molecule	5 mg	Oral
Subject	Icalcaprant	Small molecule	10 mg	Oral
Subject	Icalcaprant	Small molecule	15 mg	Oral
Subject	Icalcaprant	Small molecule	25 mg	Oral
Subject	Icalcaprant	Small molecule	45 mg	Oral
Subject	Icalcaprant	Small molecule	50 mg	Oral
Subject	Icalcaprant	Small molecule	80 mg	Oral
Subject	Icalcaprant	Small molecule	85 mg	Oral
Subject	Icalcaprant	Small molecule	90 mg	Oral
Subject	Icalcaprant	Small molecule	150 mg	Oral
Subject	Icalcaprant	Small molecule	200 mg	Oral

Indications

No indication recorded.