A Study of JNJ-67835989 in Healthy Participants

NCT ID: NCT04844411

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2022-05-18

Brief 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

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-67835989

Intervention Type: DRUG

JNJ-67835989 will be administered orally.

Arm B: Placebo

Participants will receive a single oral solution placebo on Day 1 in Part 1 only (except food effect cohorts).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be administered orally.

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.

Group Type: EXPERIMENTAL

JNJ-67835989

Intervention Type: DRUG

JNJ-67835989 will be administered orally.

Interventions

JNJ-67835989

JNJ-67835989 will be administered orally.

Intervention Type: DRUG

Placebo

Matching placebo will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2021-000337-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67835989EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108974

Identifier Type: -

Identifier Source: org_study_id