The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Oral capsules.
Oral extended-release (ER) tablets.
Dr. Vince Clinical Research
Overland Park, Kansas, United States
Maximum Observed Concentration (Cmax) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Area Under the Curve from Time Zero to Last Measurable Concentration (AUC0-t) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Area Under the Curve from Time Zero to Infinity (AUCinfinity) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Time to Maximum Concentration (Tmax) of SEP-380135 and its Metabolites
Time frame: Up to Day 11
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Neurological Examinations
Time frame: Up to 2 months
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
Time frame: Up to 2 months
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Number of Participants With Incidence of Suicidal Behavior, Suicidal Ideation and Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 2 months