A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Cerevel Therapeutics, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to avoid certain medications, including prescription and over-the-counter drugs, herbal medications, vitamins, and supplements. You may need to stop taking your current medications if they are considered prohibited for the trial.
Research Team
ML
Matthew Leoni, MD, MBA
Principal Investigator
Cerevel Therapeutics, LLC
Eligibility Criteria
Inclusion Criteria
A man who is participating in the trial and who has a pregnant or partner who is able to have children must agree to use contraception during the trial and for 14 days after the last dose of study drug.
Capable of giving signed informed consent
The person's body mass index is between 18.5 and 30.0 kg/m2, and their total body weight is over 50 kg.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part A
Participants receive single ascending doses of CVL-354 in a 4-way crossover design with washout periods
Up to 72 days
Treatment Part B
Participants receive multiple ascending doses of CVL-354 or placebo once daily for 14 days
Up to 31 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 72 days
Treatment Details
Interventions
- CVL-354
- Placebo
Participant Groups
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.
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Who Is Running the Clinical Trial?
Cerevel Therapeutics, LLC
Lead Sponsor
Trials
37
Recruited
5,500+
National Institute on Drug Abuse (NIDA)
Collaborator
Trials
2,658
Recruited
3,409,000+
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