The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of emraclidine on the PK of metformin in Part C in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Emraclidine tablets.
Itraconazole oral solution.
Carbamazepine tablets.
Metformin tablets.
Overland Park, Kansas
Overland Park, Kansas, United States
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: Cmax of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: Cmax of Metformin
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: 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 time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUC0-t of Metformin
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Part A: 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 time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
Part B: AUCinf of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
Part C: AUCinf of Metformin
Time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity
Time frame: From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
Changes in Suicidality Assessed Using the 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 the 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 end of treatment in each part of the study (up to an average of 15 days)
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