A Phase 1 interventional study of Emraclidine in Healthy, sponsored by Cerevel Therapeutics, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Cerevel Therapeutics, LLC · Phase 1, Interventional, and Treatment
The primary purpose of this study is to evaluate the effect of food (a high-fat meal) on the pharmacokinetics of emraclidine and metabolite CV-0000364 following single oral dose administration in healthy adult participants.
Cerevel Therapeutics, LLC is the lead sponsor of 20 studies on the registry; none are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Sexually active women of childbearing potential must agree to use an acceptable birth control method, during the trial and for 7 days after the last dose. Acceptable birth control methods that result in a failure rate of more than 1% per year include the following:
Exclusion Criteria:
"Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
Any of the following clinical laboratory test results at the Screening Visit (as assessed by the central laboratory) and at Check-in (Day -1; as assessed by the local laboratory), and confirmed by a single repeat measurement, if deemed necessary:
Single oral dose of Emraclidine 15 mg tablet under fasted (without food) condition followed by fed condition in treatment period 1 and 2, respectively.
Drug: Emraclidine
Single oral dose of Emraclidine 15 mg tablet under fed condition followed by fasted (without food) condition in treatment period 1 and 2, respectively.
Drug: Emraclidine
Tablets
Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple timepoints up to Day 6
Time to Maximum Plasma Concentration (Tmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple timepoints up to Day 6
Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple timepoints up to Day 6
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple timepoints up to Day 6
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 13
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Time frame: Up to Day 13
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Cerevel Therapeutics, LLC