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Completed

NCT Number: NCT05197062

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

14C-aticaprant

Drug

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

Other names: JNJ-67953964

Primary outcomes

  1. Plasma Concentrations of Aticaprant and its Metabolite M3

    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.

  2. Duodenal Concentrations of Aticaprant and its Metabolite M3

    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.

  3. Urine Concentration of Aticaprant and its Metabolites M3

    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.

  4. Total Radioactivity Concentration of 14C-aticaprant in Whole Blood

    Time frame: Pre-dose up to Day 14

    Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting.

  5. Total Radioactivity Concentration of 14C-aticaprant in Plasma

    Time frame: Pre-dose up to Day 14

    Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.

  6. Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid

    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.

  7. Amount of Total Radioactivity of 14C-aticaprant in Urine

    Time frame: Up to Day 32

    Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.

  8. Amount of Total Radioactivity of 14C-aticaprant in Feces

    Time frame: Up to Day 32

    Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting.

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    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.

  2. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Day 67

    Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported.

  3. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 67

    Number of participants with ECG abnormalities will be reported.

  4. Number of Participants with Vital Signs Abnormalities

    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.

  5. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to Day 67

    Number of participants with physical examination abnormalities will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2022
Registry last updated
Apr 27, 2025

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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