This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.
The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Tablets
Celerion Inc.
Tempe, Arizona, United States
Single Dose: Peak Plasma Concentrations
Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions
Time frame: Day 1 to Day 4
Single Dose: Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUC) for Darigabat under fasted conditions
Time frame: Day 1 to Day 4
Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured
Area under the plasma concentration-time curve from time zero to last concentration measured (AUClast) for Darigabat under fasted conditions
Time frame: Day 1 to Day 4
Single Dose: Time of Maximum Observed Plasma Concentrations
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted conditions
Time frame: Day 1 to Day 4
Secondary Objective: Single Dose: Peak Plasma Concentrations
Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions
Time frame: Day 1 to Day 4
Secondary Objective: Single Dose: Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUC) for Darigabat under fed and fasted conditions
Time frame: Day 1 to Day 4
Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-865 under fed and fasted conditions
Time frame: Day 1 to Day 4
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Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted and fed conditions
Time frame: Day 1 to Day 4
Secondary Outcome (AE)
Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 4
Secondary Outcome (ECGs)
Number of subjects with clinically significant changes in Electrocardiograms.
Time frame: Day 1 to Day 4
Secondary Outcome (Labs)
Number of subjects with clinically significant changes in laboratory measures.
Time frame: Day 1 to Day 4
Secondary Outcome (Vital Signs)
Number of subjects with clinically meaningful changes in vitals signs.
Time frame: Day 1 to Day 4
Secondary Outcome (Physical/Neurological Exam)
Number of subjects with clinically significant changes in physical and neurological exams.
Time frame: Day 1 to Day 4
Secondary Outcome (C-SSRS)
Changes from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Time frame: Day 1 to Day 4