The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of \[14C\]-darigabat in healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral capsule
Austin, Texas
Austin, Texas, United States
Area Under the Concentration Time Curve (AUC) from Time Zero to Infinity (AUCinf) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
AUC from Time 0 to the Time of the Last Measured Concentration (AUClast) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Maximum Observed Plasma Concentration (Cmax) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time to Last Quantifiable (Tlast) Concentration of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time to Maximum Observed Concentration (Tmax) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Terminal Phase Half-life (t½) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Apparent Total Clearance After Oral Administration (CL/F) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Darigabat
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Ratio of Plasma AUCinf for Darigabat to Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma Total Radioactivity
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Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Amount Excreted in Urine (Aeu) of Total Radioactivity
Urine PK parameters will be assessed.
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Amount Excreted in Feces (Aef) of Total Radioactivity
Fecal PK parameters will be assessed.
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Metabolite Profile of [14C]-darigabat in Plasma, Urine and Feces
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Identification of [14C]-darigabat Metabolites Found in Plasma, Urine and Feces
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Structural Elucidation of [14C]-darigabat Metabolites ≥10% of the Total [14C]-darigabat Radioactivity Found in Plasma, Urine and Feces
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 16
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to Day 15
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 15
Number of Participants with Clinically Significant Changes in Laboratory Assessments
Time frame: Up to Day 15
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 15