PRA Health Sciences
Groningen, NZ 9728, Netherlands
NCT Number: NCT05197062
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Groningen, NZ 9728, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
14C-aticaprant will be administered orally as capsule on Day 1.
Other names: JNJ-67953964
Time frame: Up to Day 39
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: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
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 up to Day 32
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 14
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 will be performed via liquid scintillation counting.
Time frame: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting.
Time frame: Up to Day 32
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 will be performed via liquid scintillation counting.
Time frame: Up to Day 67
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 (including serum chemistry, hematology and urinalysis) will be reported.
Time frame: Up to Day 67
Number of participants with ECG abnormalities will be reported.
Time frame: Up to Day 67
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 will be reported.
Janssen Research & Development, LLC
Industry
A Phase 1, Open Label Study to Characterize the Absorption, Metabolism, and Excretion of 14C JNJ-67953964 After a Single Dose in Healthy Adult Male Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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