HealthyPhase 1NCT02674295
A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
A Phase 1 study testing Esketamine 50 mg and Esketamine 20 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy 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?
- Esketamine 50 mg and Esketamine 20 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2016
- 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
- Participants willing to adhere to the prohibitions and restrictions specified in the protocol
- If a man who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) for 3 months following administration of study drug
- Participants with body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Note: Average from 3 supine measurements will be used at screening visit
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm; Heart rate between 45 and 90 beats per minute (bpm); QTc interval less than or equal to (<=)450 milliseconds (ms); QRS interval of <110 ms; PR interval <200 ms; Morphology consistent with healthy cardiac conduction and function
Who cannot join
- Participants diagnosed with a current or previous psychiatric or bipolar disorder, as assessed by the investigator, will not be permitted to participate in the study
- Current suicidal or homicidal ideation/intent/behavior as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) at screening
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or Day -1, and as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before study drug administration is scheduled, except for acetaminophen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Subjects
The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
Read the detailed description
This is a single-center, open-label (identity of study drug will be known to participant and study staff), single-dose, parallel-group study. The study consist of Screening Phase (Days -21 to -2), Open-label treatment Phase (Day -1 up to Day 8) and End of Study (9 to 13 days after last study assessment). The total duration of study from the Screening Phase through Follow-up, is 37-41 days. Participants will be assigned to 1 of the two groups (Cohort 1 and Cohort 2) during the treatment phase. The participants will be primarily evaluated to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Esketamine 50 mg, Esketamine 20 mg
- Keywords
- Healthy, JNJ-54135419, Esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine 50 mgDrug
50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume)
Esketamine 20 mgDrug
20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 50 milligram (mg) of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration. Receives: Drug: Esketamine 50 mg |
| Cohort 2 | Experimental | 20 mg of intravenous esketamine in 30 milliliter (mL), fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion. Receives: Drug: Esketamine 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation and Identification of 14C-esketamine Metabolites (Metabolic Profile)
Collection of urine and feces for 7 days is considered appropriate to characterize the metabolic profile of esketamine. Accelerator mass spectrometry (AMS), an ultrasensitive technique particularly suited for detection of low levels of 14C, will be used to assess levels of the microtracer in whole blood, plasma, and excreta (urine, feces). Plasma, urine and feces selected samples with relatively high radioactive content will be analyzed for metabolic profiling and identification using ultra performance liquid chromatography (UPLC) and AMS.
Measured: upto 168 hour post-dose
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs) or Serious Adverse Events
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: up to 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
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
- Other
- Allocation
- Randomised
- 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
- NCT02674295
- Sponsor's protocol ID
- CR108107
- Other IDs
- 54135419TRD1016
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02674295
- Acronym / sponsor ID
- CR108107
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-54135419, Esketamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Feb 2016 (estimated)
- 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 determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
Detailed description
This is a single-center, open-label (identity of study drug will be known to participant and study staff), single-dose, parallel-group study. The study consist of Screening Phase (Days -21 to -2), Open-label treatment Phase (Day -1 up to Day 8) and End of Study (9 to 13 days after last study assessment). The total duration of study from the Screening Phase through Follow-up, is 37-41 days. Participants will be assigned to 1 of the two groups (Cohort 1 and Cohort 2) during the treatment phase. The participants will be primarily evaluated to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Esketamine 50 mg50 milligram (mg) of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration. |
| Cohort 2 | Experimental | Drug: Esketamine 20 mg20 mg of intravenous esketamine in 30 milliliter (mL), fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants willing to adhere to the prohibitions and restrictions specified in the protocol
- If a man who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) for 3 months following administration of study drug
- Participants with body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Note: Average from 3 supine measurements will be used at screening visit
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm; Heart rate between 45 and 90 beats per minute (bpm); QTc interval less than or equal to (<=)450 milliseconds (ms); QRS interval of <110 ms; PR interval <200 ms; Morphology consistent with healthy cardiac conduction and function
Key exclusion criteria (5 listed)
- Participants diagnosed with a current or previous psychiatric or bipolar disorder, as assessed by the investigator, will not be permitted to participate in the study
- Current suicidal or homicidal ideation/intent/behavior as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) at screening
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or Day -1, and as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before study drug administration is scheduled, except for acetaminophen
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 |
|---|---|---|
| Esketamine 50 mg50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume) | Drug | Cohort 1 |
| Esketamine 20 mg20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion. | Drug | Cohort 2 |
Primary outcome
Characterisation and Identification of 14C-esketamine Metabolites (Metabolic Profile)
Time frame: upto 168 hour post-dose
Collection of urine and feces for 7 days is considered appropriate to characterize the metabolic profile of esketamine. Accelerator mass spectrometry (AMS), an ultrasensitive technique particularly suited for detection of low levels of 14C, will be used to assess levels of the microtracer in whole blood, plasma, and excreta (urine, feces). Plasma, urine and feces selected samples with relatively high radioactive content will be analyzed for metabolic profiling and identification using ultra performance liquid chromatography (UPLC) and AMS.
1 secondary outcome
Number of Participants With Adverse Events (AEs) or Serious Adverse Events
Time frame: up to 41 days
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 3 Feb 2025.
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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 Esketamine 50 mg and Esketamine 20 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 3 Feb 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 United States. 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?
Characterisation and Identification of 14C-esketamine Metabolites (Metabolic Profile) (time frame: upto 168 hour post-dose). 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 3 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.