Status:
COMPLETED
A Study of 14C JNJ-67953964 in Healthy Adult Male Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05197062
Start Date
January 14 2022
End Date
March 2 2022
Last Update
April 27 2025
Active Locations (1)
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1
PRA Health Sciences
Groningen, Netherlands, NZ 9728