A Study of 14C JNJ-67953964 in Healthy Adult Male Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197062
• Other study ID #: CR109135
• Secondary ID: 2021-005130-4267
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2022
• Est. completion date: March 2, 2022

Study information

• Verified date: April 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 14C-aticaprant
14C-aticaprant will be administered orally as capsule on Day 1.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Day 39
Primary	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.	Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Primary	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.	Pre-dose up to Day 32
Primary	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.	Pre-dose up to Day 14
Primary	Total Radioactivity Concentration of 14C-aticaprant in Plasma	Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.	Pre-dose up to Day 14
Primary	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.	Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Primary	Amount of Total Radioactivity of 14C-aticaprant in Urine	Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.	Up to Day 32
Primary	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.	Up to Day 32
Secondary	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.	Up to Day 67
Secondary	Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported.	Up to Day 67
Secondary	Number of Participants with Electrocardiogram (ECG) Abnormalities	Number of participants with ECG abnormalities will be reported.	Up to Day 67
Secondary	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.	Up to Day 67
Secondary	Number of Participants with Physical Examination Abnormalities	Number of participants with physical examination abnormalities will be reported.	Up to Day 67