HealthyPhase 1NCT05197062
A Study of 14C JNJ-67953964 in Healthy Adult Male Participants
A Phase 1 study testing 14C-aticaprant in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C-aticaprant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jan 2022to 2 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- 14C-aticaprant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-aticaprantDrug
Also called JNJ-67953964
14C-aticaprant will be administered orally as capsule on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 14C-aticaprant | Experimental | 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. Receives: Drug: 14C-aticaprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 39
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.
Measured: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
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.
Measured: Pre-dose up to Day 32
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.
Measured: Pre-dose up to Day 14
Total Radioactivity Concentration of 14C-aticaprant in Plasma
Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.
Measured: Pre-dose up to Day 14
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.
Measured: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
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.
Measured: Up to Day 32
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.
Measured: Up to Day 32
Secondary outcomes (5)
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.
Measured: Up to Day 67
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported.
Measured: Up to Day 67
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with ECG abnormalities will be reported.
Measured: Up to Day 67
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.
Measured: Up to Day 67
Number of Participants with Physical Examination Abnormalities
Number of participants with physical examination abnormalities will be reported.
Measured: Up to Day 67
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start14 Jan 2022
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197062
- Sponsor's protocol ID
- CR109135
- Other IDs
- 2021-005130-42, 67953964MDD1002
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05197062
- Acronym / sponsor ID
- CR109135
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-aticaprant | Experimental | Drug: 14C-aticaprantParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-aticaprantAlso: JNJ-6795396414C-aticaprant will be administered orally as capsule on Day 1. | Drug | 14C-aticaprant |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 67
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to Day 67
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 67
Number of Participants with Vital Signs Abnormalities
Time frame: Up to Day 67
Number of Participants with Physical Examination Abnormalities
Time frame: Up to Day 67
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-aticaprant in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentrations of Aticaprant and its Metabolite M3 (time frame: Up to Day 39). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.