A Study of 14C JNJ-67953964 in Healthy Adult Male Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 14C-aticaprant Participants in Group A (without duodenal fluid collection) and Group B (with duodenal fluid collection) will receive a single oral dose of 14C-aticaprant on Day 1. |
Drug: 14C-aticaprant
14C-aticaprant will be administered orally as capsule on Day 1.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Plasma Concentrations of Aticaprant and its Metabolite M3 [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.
- Duodenal Concentrations of Aticaprant and its Metabolite M3 [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.
- Urine Concentration of Aticaprant and its Metabolites M3 [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.
- Total Radioactivity Concentration of 14C-aticaprant in Whole Blood [Pre-dose up to Day 14]
Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting.
- Total Radioactivity Concentration of 14C-aticaprant in Plasma [Pre-dose up to Day 14]
Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.
- Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid [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.
- Amount of Total Radioactivity of 14C-aticaprant in Urine [Up to Day 32]
Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.
- Amount of Total Radioactivity of 14C-aticaprant in Feces [Up to Day 32]
Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting.
Secondary Outcome Measures
- Number of Participants with Adverse Events (AEs) [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.
- Number of Participants with Clinical Laboratory Abnormalities [Up to Day 67]
Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported.
- Number of Participants with Electrocardiogram (ECG) Abnormalities [Up to Day 67]
Number of participants with ECG abnormalities will be reported.
- Number of Participants with Vital Signs Abnormalities [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.
- Number of Participants with Physical Examination Abnormalities [Up to Day 67]
Number of participants with physical examination abnormalities will be reported.
Eligibility Criteria
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]/height2 [m2]) 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRA Health Sciences | Groningen | Netherlands | NZ 9728 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109135
- 2021-005130-42
- 67953964MDD1002