A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy Adult Participants
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Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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Call us @: 844 663-3742
| Location | Status | Site Contact Details |
|---|---|---|
Location Overland Park, Kansas, Overland Park, Kansas, 66212 | Status Not Available |
The purpose of this trial is to evaluate plasma concentrations of emraclidine following single dose oral administration of different emraclidine immediate release (IR) tablets in healthy participants.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 4 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Time Frame: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time Frame: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time Frame: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame: Screening up to checkout (up to approximately 4 months)
Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to approximately 4 months
Interventions:
- Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
- Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
- Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
- Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
- Drug: Treatment B: Emraclidine 30mg IR test tablets 1
- Drug: Treatment B: Emraclidine 30mg IR test tablets 1
- Drug: Treatment B: Emraclidine 30mg IR test tablets 1
- Drug: Treatment B: Emraclidine 30mg IR test tablets 1
- Drug: Treatment C: Emraclidine 30mg IR test tablets 2
- Drug: Treatment C: Emraclidine 30mg IR test tablets 2
- Drug: Treatment C: Emraclidine 30mg IR test tablets 2
- Drug: Treatment C: Emraclidine 30mg IR test tablets 2
- Drug: Treatment D: Emraclidine 30mg IR test tablets 3
- Drug: Treatment D: Emraclidine 30mg IR test tablets 3
- Drug: Treatment D: Emraclidine 30mg IR test tablets 3
- Drug: Treatment D: Emraclidine 30mg IR test tablets 3
Enrollment:
15
Additional Information
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