The primary purpose of the study is to evaluate the effect of increased metabolizing enzyme (cytochrome P450 \[CYP\] 3A4) due to carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of darigabat in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Oral tablet
Oral tablets
Orlando, Florida
Orlando, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of Darigabat
PK of darigabat will be analyzed both in the presence and absence of carbamazepine.
Time frame: Treatment Period 1: 15 minutes pre-dose on Day 1 and up to 48 hours post dose; Treatment Period 2: 15 minutes pre-dose on Day 16 and up to 48 hours post dose
Area Under the Plasma Concentration-time Curve up to the Last Specified Sampling Time (AUC0-t) of Darigabat
PK of darigabat will be analyzed both in the presence and absence of carbamazepine.
Time frame: Treatment Period 1: 15 minutes pre-dose on Day 1 and up to 48 hours post dose; Treatment Period 2: 15 minutes pre-dose on Day 16 and up to 48 hours post dose
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Darigabat
PK of darigabat will be analyzed both in the presence and absence of carbamazepine.
Time frame: Treatment Period 1: 15 minutes pre-dose on Day 1 and up to 48 hours post dose; Treatment Period 2: 15 minutes pre-dose on Day 16 and up to 48 hours post dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 52
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to Day 21
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time frame: Up to Day 21
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Up to Day 21
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Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 21
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
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 21