The purpose of this study is to assess the pharmacokinetic (PK), metabolism, and routes of excretion of aticaprant and its metabolites in excreta and in plasma after a single oral dose 14C-aticaprant in healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
14C-aticaprant will be administered orally as capsule on Day 1.
PRA Health Sciences
Groningen, Netherlands
Plasma Concentrations of Aticaprant and its Metabolite M3
Plasma samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a validated, specific, and sensitive liquid chromatography (LC)-mass spectrometry (MS)/MS method.
Time frame: Up to Day 39
Duodenal Concentrations of Aticaprant and its Metabolite M3
Duodenal fluid samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Time frame: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Urine Concentration of Aticaprant and its Metabolites M3
Urine samples will be analyzed to determine concentrations of aticaprant and its metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Time frame: Pre-dose up to Day 32
Total Radioactivity Concentration of 14C-aticaprant in Whole Blood
Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting.
Time frame: Pre-dose up to Day 14
Total Radioactivity Concentration of 14C-aticaprant in Plasma
Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.
Time frame: Pre-dose up to Day 14
Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid
Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting.
Time frame: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Amount of Total Radioactivity of 14C-aticaprant in Urine
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Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.
Time frame: Up to Day 32
Amount of Total Radioactivity of 14C-aticaprant in Feces
Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting.
Time frame: Up to Day 32
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: Up to Day 67
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported.
Time frame: Up to Day 67
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with ECG abnormalities will be reported.
Time frame: Up to Day 67
Number of Participants with Vital Signs Abnormalities
Number of participants with vital signs abnormalities (including body temperature, pulse rate, respiratory rate, blood pressure \[systolic and diastolic\]) will be reported.
Time frame: Up to Day 67
Number of Participants with Physical Examination Abnormalities
Number of participants with physical examination abnormalities will be reported.
Time frame: Up to Day 67