← Back to Search

Unknown

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

Phase 1

Waitlist Available

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose of study drug up to end of treatment (up to 72 days)

Summary

This trial tests a new drug called CVL-354 in humans for the first time. It aims to find out how safe it is and what the right dose should be. The study likely involves healthy volunteers to understand how the drug works in the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of study drug up to end of treatment (up to 72 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first dose of study drug up to end of treatment (up to 72 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug up to end of treatment (up to 72 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Cohort 3: Number of Participants With Changes in C-SSRS

Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations

Part A: Cohort 3: Number of Participants With TEAEs

+15 more

Trial Design

15Treatment groups

Experimental Treatment

Group I: Part B: Cohort 5: CVL-354 85 mgExperimental Treatment2 Interventions

Participants received oral dose of CVL-354 85 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 5.

Group II: Part B: Cohort 4: CVL-354 80 mgExperimental Treatment2 Interventions

Participants received oral dose of CVL-354 80 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 4.

Group III: Part B: Cohort 3: CVL-354 50 mgExperimental Treatment2 Interventions

Participants received oral dose of CVL-354 50 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 3.

Group IV: Part B: Cohort 2: CVL-354 25 mgExperimental Treatment2 Interventions

Participants received oral dose of CVL-354 25 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 2.

Group V: Part B: Cohort 1: CVL-354 10 mgExperimental Treatment2 Interventions

Participants received oral dose of CVL-354 10 mg or Placebo, once daily (QD) from Day 1 up to Day 14 in Cohort 1.

Group VI: Part A: Cohort 3: Sequence 2: Fasted/Fed SequenceExperimental Treatment1 Intervention

Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods

Group VII: Part A: Cohort 3: Sequence 1: Fed/Fasted SequenceExperimental Treatment1 Intervention

Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods.

Group VIII: Part A: Cohort 2: Sequence 4Experimental Treatment2 Interventions

Participants were randomized to sequence 4 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group IX: Part A: Cohort 2: Sequence 3Experimental Treatment2 Interventions

Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group X: Part A: Cohort 2: Sequence 2Experimental Treatment2 Interventions

Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group XI: Part A: Cohort 2: Sequence 1Experimental Treatment2 Interventions

Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group XII: Part A: Cohort 1: Sequence 4Experimental Treatment2 Interventions

Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group XIII: Part A: Cohort 1: Sequence 3Experimental Treatment2 Interventions

Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group XIV: Part A: Cohort 1: Sequence 2Experimental Treatment2 Interventions

Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Group XV: Part A: Cohort 1: Sequence 1Experimental Treatment2 Interventions

Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 milligrams (mg) on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

CVL-354

2021

Completed Phase 1

~100