The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Oral tablets
Tustin, California
Tustin, California, United States
Miami, Florida
Miami, Florida, United States
Miami, Florida
Miami, Florida, United States
Orlando, Florida
Orlando, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 15
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to Day 5
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to Day 5
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Knoxville, Tennessee
Knoxville, Tennessee, United States
Number of Participants With Clinically Significant Change in Laboratory Assessments
Time frame: Up to Day 5
Number of Participants With Clinically Significant Change in Physical and Neurological Examination Results
Time frame: Up to Day 5
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
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 5