HealthyPhase 1NCT04844411

A Study of JNJ-67835989 in Healthy Participants

A Phase 1 study testing JNJ-67835989 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: JNJ-67835989
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: 1 siteBelgium
Study dates: 27 Apr 2021to 18 May 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 and neurological examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of complete Left Bundle Branch Block (LBBB), atrioventricular (AV) block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD) will lead to exclusion. Heart rate must be less than or equal to (<=) 90 beats per minute (bpm)
Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, including liver enzymes, blood coagulation, hematology, thyroid function or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Body mass index (BMI) within the range 18.0 and 29.9 kilograms per meter square (kg/m^2) (inclusive)
A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak
Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study. Participation in the pharmacogenomic part of the study is mandatory
Willing and able to adhere to the lifestyle restrictions specified in this protocol
Part 2 only: Participants should be moderate to heavy cigarette smokers (at least 10 cigarettes per day; no e-cigarettes or cigars) for at least the 3 months prior to screening. Smoking will be allowed at specific times each day during the study as defined by site staff. Participants should continue their smoking behavior during the complete study period until at least after the follow-up visit

Who cannot join

History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hypertension, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, parkinson's disease, psychiatric disorders, infection, or any other illness that the investigator considers should exclude the participant
History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy that in the opinion of the investigator, with written concurrence with the safety responsible physician, is considered cured with minimal risk of recurrence)
Systolic blood pressure greater than (>)140 millimeters of mercury (mmHg), diastolic blood pressure >90 mmHg or respiratory rate > 18 at screening
Has had coronavirus disease (COVID) as confirmed by a positive severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) test (polymerase chain reaction [PCR] or rapid antigen test, not an antibody test) within the past 3 months and/or has required hospitalization for treatment of COVID at any timepoint and/or has reported sequelae from COVID at screening
Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days (or 5 half-lives whichever is longest) before the planned first dose of study intervention or is currently enrolled in an investigational study
For Parts 1 and 3 only: Smokes cigarettes (or equivalent) and/or has used nicotine-based products within 3 months prior to screening
For Parts 1 and 3 only: Positive urine cotinine dipstick test at screening or admission

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Clinical Pharmacology Unit
Merksem, 2170

Other trials in Belgium

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-67835989 in Healthy Participants

The purpose of this study is to investigate the safety and tolerability of JNJ-67835989 versus placebo after single (or divided) oral dose administration (ascending dose levels) in healthy participants, pharmacokinetics (PK) of JNJ-67835989 in plasma and urine after single (or divided) oral dose administration in healthy participants, effects of JNJ-67835989 following single (or divided) oral dose administration in healthy participants on cardiovascular parameters, effects of JNJ-67835989 following single (or divided) oral dose administration on dissociative symptoms in healthy participants, and sedative effects of JNJ-67835989 following single (or divided) oral dose administration in healthy participants.

Conditions: Healthy
Being tested: JNJ-67835989, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-67835989Drug
JNJ-67835989 will be administered orally.
PlaceboDrug
Matching placebo will be administered orally.

Study groups in NCT04844411
Study group	Role	What they receive
Arm A: JNJ-67835989 (Oral Suspension)	Experimental	Participants will receive a single oral suspension dose of JNJ-67835989 on Day 1 in Part 1 and Part 2. Receives: Drug: JNJ-67835989
Arm B: Placebo	Placebo comparator	Participants will receive a single oral solution placebo on Day 1 in Part 1 only (except food effect cohorts). Receives: Drug: Placebo
Arm C: JNJ-67835989 (Oral Solid Dose)	Experimental	Participants will receive a single oral solid dose (tablet) of JNJ-67835989 on Day 1 in Part 3. Receives: Drug: JNJ-67835989

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DPB]), respiratory rate, pulse oximetry and temperature will be reported.
Measured: Up to 6 weeks
Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
Number of participants with clinically significant clinical laboratory abnormalities (chemistry, hematology, urinalysis) will be reported.
Measured: Up to 6 weeks
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 6 weeks
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Measured: Up to 6 weeks
Plasma Concentrations of JNJ-67835989 and Possible Metabolites
Plasma samples will be analyzed to determine concentrations of JNJ-67835989 and possible metabolites using a validated, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC MS/MS) method.
Measured: Predose, up to 48 hours post dose (up to Day 3)
Urine Concentrations of JNJ-67835989 and Possible Metabolites
Urine samples will be analyzed to determine JNJ-67835989 and possible metabolites concentrations using a qualified research LC-MS/MS method.
Measured: Predose, up to 72 hours post dose (up to Day 4)
Number of Participants with Clinician-Administered Dissociative States Scale (CADSS) Score
CADSS is an instrument for the measurement of present-state dissociative symptoms and will be administered to assess treatment-emergent dissociative symptoms. CADSS consists of 23 subjective items, divided into 3 components: depersonalization (items 3 to 7, 20, and 23), derealization (items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (items 14, 15, and 22). The participants responses are coded on a 5-point scale (from 0 equals to [=] not at all to 4=extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
Measured: Up to Day 1
Number of Participants with Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) Scores
The MOAA/S will be used to measure treatment-emergent sedation, with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum. The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).
Measured: Up to Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 202118 May 2022

First posted14 Apr 2021
Study start27 Apr 2021
Primary completion18 May 2022
Study completion18 May 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: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04844411
Sponsor's protocol ID: CR108974
Other IDs: 2021-000337-14, 67835989EDI1001
Status last verified: Apr 2025
First submitted: 12 Apr 2021
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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 Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-67835989 in Healthy Participants
ClinicalTrials.gov ID: NCT04844411
Acronym / sponsor ID: CR108974
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 27 Apr 2021 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 18 May 2022 (actual)
First posted: 14 Apr 2021 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Arm A: JNJ-67835989 (Oral Suspension)	Experimental	Drug: JNJ-67835989Participants will receive a single oral suspension dose of JNJ-67835989 on Day 1 in Part 1 and Part 2.
Arm B: Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a single oral solution placebo on Day 1 in Part 1 only (except food effect cohorts).
Arm C: JNJ-67835989 (Oral Solid Dose)	Experimental	Drug: JNJ-67835989Participants will receive a single oral solid dose (tablet) of JNJ-67835989 on Day 1 in Part 3.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy on the basis of physical and neurological examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of complete Left Bundle Branch Block (LBBB), atrioventricular (AV) block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD) will lead to exclusion. Heart rate must be less than or equal to (<=) 90 beats per minute (bpm)
Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, including liver enzymes, blood coagulation, hematology, thyroid function or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Body mass index (BMI) within the range 18.0 and 29.9 kilograms per meter square (kg/m^2) (inclusive)
A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak
Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study. Participation in the pharmacogenomic part of the study is mandatory

Key exclusion criteria (7 listed)

History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hypertension, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, parkinson's disease, psychiatric disorders, infection, or any other illness that the investigator considers should exclude the participant
History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy that in the opinion of the investigator, with written concurrence with the safety responsible physician, is considered cured with minimal risk of recurrence)
Systolic blood pressure greater than (>)140 millimeters of mercury (mmHg), diastolic blood pressure >90 mmHg or respiratory rate > 18 at screening
Has had coronavirus disease (COVID) as confirmed by a positive severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) test (polymerase chain reaction [PCR] or rapid antigen test, not an antibody test) within the past 3 months and/or has required hospitalization for treatment of COVID at any timepoint and/or has reported sequelae from COVID at screening
Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days (or 5 half-lives whichever is longest) before the planned first dose of study intervention or is currently enrolled in an investigational study

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
JNJ-67835989JNJ-67835989 will be administered orally.	Drug	Arm A: JNJ-67835989 (Oral Suspension), Arm C: JNJ-67835989 (Oral Solid Dose)
PlaceboMatching placebo will be administered orally.	Drug	Arm B: Placebo

Primary outcome

Number of Participants with Abnormalities in Vital Signs
Time frame: Up to 6 weeks
Number of participants with abnormalities in vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DPB]), respiratory rate, pulse oximetry and temperature will be reported.
Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
Time frame: Up to 6 weeks
Number of participants with clinically significant clinical laboratory abnormalities (chemistry, hematology, urinalysis) will be reported.
Number of Participants with Adverse Events (AEs)
Time frame: Up to 6 weeks
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Time frame: Up to 6 weeks
Number of participants with abnormalities in ECG will be reported.
Plasma Concentrations of JNJ-67835989 and Possible Metabolites
Time frame: Predose, up to 48 hours post dose (up to Day 3)
Plasma samples will be analyzed to determine concentrations of JNJ-67835989 and possible metabolites using a validated, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC MS/MS) method.
Urine Concentrations of JNJ-67835989 and Possible Metabolites
Time frame: Predose, up to 72 hours post dose (up to Day 4)
Urine samples will be analyzed to determine JNJ-67835989 and possible metabolites concentrations using a qualified research LC-MS/MS method.
Number of Participants with Clinician-Administered Dissociative States Scale (CADSS) Score
Time frame: Up to Day 1
CADSS is an instrument for the measurement of present-state dissociative symptoms and will be administered to assess treatment-emergent dissociative symptoms. CADSS consists of 23 subjective items, divided into 3 components: depersonalization (items 3 to 7, 20, and 23), derealization (items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (items 14, 15, and 22). The participants responses are coded on a 5-point scale (from 0 equals to [=] not at all to 4=extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
Number of Participants with Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) Scores
Time frame: Up to Day 1
The MOAA/S will be used to measure treatment-emergent sedation, with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum. The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).

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 JNJ-67835989 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 7 inclusion and 7 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 Belgium. 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. Some participants in this study may receive a placebo. 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?

Number of Participants with Abnormalities in Vital Signs (time frame: Up to 6 weeks). 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?

On the ClinicalTrials.gov record for NCT04844411.

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.