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Sequence 1: A-B-C-D for Healthy Subjects
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 up to approximately 4 months
Awards & highlights
Study Summary
This trial tests how well different versions of a drug are absorbed by the body when taken orally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine
Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
+1 moreSecondary outcome measures
Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Sequence 4: D-A-B-CExperimental Treatment4 Interventions
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence D-A-B-C orally, on Day 1 of each 5-day treatment period (up to 26 days)
Group II: Sequence 3: C-D-A-BExperimental Treatment4 Interventions
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence C-D-A-B orally, on Day 1 of each 5-day treatment period (up to 26 days)
Group III: Sequence 2: B-C-D-AExperimental Treatment4 Interventions
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence B-C-D-A orally, on Day 1 of each 5-day treatment period (up to 26 days)
Group IV: Sequence 1: A-B-C-DExperimental Treatment4 Interventions
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence A-B-C-D orally, on Day 1 of each 5-day treatment period (up to 26 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment A: Emraclidine 30mg IR tablets (reference)
2023
Completed Phase 1
~20
Treatment B: Emraclidine 30mg IR test tablets 1
2023
Completed Phase 1
~20
Treatment C: Emraclidine 30mg IR test tablets 2
2023
Completed Phase 1
~20
Treatment D: Emraclidine 30mg IR test tablets 3
2023
Completed Phase 1
~20
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical history of serious heart, lung, stomach, kidney, liver, metabolic, urinary, hormonal, blood, immune, brain, or mental health problems that could affect your safety or the trial results.You have answered "yes" to any of the following questions about thoughts or actions related to wanting to harm yourself:
- Have you had thoughts about wanting to harm yourself without planning to actually do it?
- Have you had thoughts about wanting to harm yourself with some intention to act, but without a specific plan?
- Have you had thoughts about wanting to harm yourself with a specific plan and intention?
- Have you actually attempted to harm yourself, had an interrupted attempt, aborted attempt, or engaged in preparatory acts or behavior related to self-harm?Within the past year, you have had thoughts of wanting to die or thoughts of actively wanting to harm yourself. The investigator also believes that you are at a serious risk of suicide.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 1: A-B-C-D
- Group 2: Sequence 2: B-C-D-A
- Group 3: Sequence 3: C-D-A-B
- Group 4: Sequence 4: D-A-B-C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility requirements to join this medical study?
"This study seeks to recruit 16 health adults, ranging from 18-55 years old. All potential participants must meet a medical baseline of wellness."
Answered by AI
What potential risks are associated with Sequence 1: A-B-C-D?
"As this is a Phase 1 trial, there are only preliminary data depicting Sequence 1: A-B-C-D's safety and efficacy; thus it has been rated as a 1 on our team at Power's scale."
Answered by AI
Is the age range for participants of this medical trial below 55 years?
"The target demographic for this medical study is individuals aged 18 to 55. Alternatively, there are 55 trials specifically tailored towards minors and 369 experiments catered to seniors over 65 years old."
Answered by AI
Are applications currently being accepted for enrolment in this clinical trial?
"The clinicaltrials.gov database communicates that this medical trial is not currently enrolling participants, despite having been originally publicised on the 1st of July 2023 and most recently amended 28th June 2023. Even though there are no opportunities to take part in this specific study at present, 789 other trials are actively recruiting individuals."
Answered by AI
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