CompletedNCT04844411Updated Apr 27, 2025

A Study of JNJ-67835989 in Healthy Participants

A Phase 1 interventional study of JNJ-67835989 and Placebo in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 109
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: Male

Study summary

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 studied

Healthy

In context

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 109 participants (actual)

Study arms

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

Interventions

DrugJNJ-67835989
JNJ-67835989 will be administered orally.
DrugPlacebo
Matching placebo will be administered orally.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 weeks
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to Day 1

Study locations

1 site

Clinical Pharmacology Unit
Merksem, 2170, Belgium

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04844411
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Apr 14, 2021
Start date: Apr 27, 2021
Primary completion: May 18, 2022
Completion: May 18, 2022
Last update: Apr 27, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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