Clinical trial NCT05197062: A Study of 14C JNJ-67953964 in Healthy Adult Male Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthy on the basis of physical examination, medical history (screening only), vital signs, and electrocardiogram (ECG) performed at screening and admission to the study site on Day -1. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
* Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight \[kg\]/height\^2 \[m\^2\]) within the range of 18.0 to 29.9 kilogram per meter square (kg/m\^2) (inclusive)
* Blood pressure (after the participant is supine for 5 minutes) between 90 millimeters of mercury (mmHg) and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and Day -1
* A 12-lead ECG consistent with normal cardiac conduction and function, at screening and Day -1, including: sinus rhythm; pulse rate between 40 and 100 beat per minutes (bpm), extremes included; QTc interval less than or equal to (\<=) 450 milliseconds (ms) for men; QRS interval of less than (\<) 120 ms; PR interval \< 210 ms; morphology consistent with healthy cardiac conduction and function
* Non-smokers (not smoked for 3 months prior to screening)

Exclusion Criteria:

* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy, which is considered cured with minimal risk of recurrence)
* Known allergies, hypersensitivity, or intolerance to aticaprant or its excipients
* History of clinically significant (example: in the opinion of the investigator) drug and/or food allergies
* Participant has presence of left bundle branch block, atrioventricular block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator
* Anatomical (nasal) abnormalities which may make the placement of the nasoduodenal tube difficult (only for participants with duodenal sampling)

Primary outcomes:
measure: Plasma Concentrations of Aticaprant and its Metabolite M3
timeFrame: Up to Day 39
measure: Duodenal Concentrations of Aticaprant and its Metabolite M3
timeFrame: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
measure: Urine Concentration of Aticaprant and its Metabolites M3
timeFrame: Pre-dose up to Day 32
measure: Total Radioactivity Concentration of 14C-aticaprant in Whole Blood
timeFrame: Pre-dose up to Day 14
measure: Total Radioactivity Concentration of 14C-aticaprant in Plasma
timeFrame: Pre-dose up to Day 14
measure: Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid
timeFrame: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
measure: Amount of Total Radioactivity of 14C-aticaprant in Urine
timeFrame: Up to Day 32
measure: Amount of Total Radioactivity of 14C-aticaprant in Feces
timeFrame: Up to Day 32
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 67
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 67
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 67
measure: Number of Participants with Vital Signs Abnormalities
timeFrame: Up to Day 67
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to Day 67
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: