TerminatedNCT04920578Updated Apr 27, 2025

A Study of JNJ-69095897 in Healthy Participants

A Phase 1 interventional study of JNJ-69095897 and Placebo in Healthy, sponsored by Janssen Research & Development, LLC. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.

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

Why this study was terminated

business decision to end clinical development of JNJ-69095897

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

The purpose of this study is to investigate the safety and tolerability of JNJ-69095897 versus placebo and to characterize the pharmacokinetic (PK) of JNJ-69095897 in blood, plasma, cerebrospinal fluid (CSF) and urine after 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 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Otherwise, healthy based on physical examination, medical history, vital signs, orthostatic blood pressure measurements and 12-lead Electrocardiography (ECG) (means of triplicate ECG, inclusive, QT corrected according to Fridericia's formula [QTcF] less than or equal to [\<=] 450 millisecond [msec] for males and \<= 470 msec for females) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, blood pressure and heart rate, which are not considered to be of clinical significance by the investigator, are acceptable, with the exception of bradycardia \<= 45 beats per minutes (bpm) on 12-lead safety ECG, that will be exclusionary at screening, admission to the clinical unit or prior to the first dose on the dosing day
Otherwise, healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, hematology, or urinalysis are outside the normal reference ranges, the participant may be included at the discretion of the investigator, provided the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
Participant has a body mass index (BMI) between 18.0 and 30.0 kilogram/meter square (kg/m\^2) inclusive (BMI=weight/height\^2)
Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
Each participant must sign an informed consent form (ICF) indicating that he or she 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

Exclusion criteria

Exclusion Criteria:

Has a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other significant cardiac disease, orthostatic hypotension, liver or renal insufficiency, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers should exclude the participant
Has a diagnosis or suspicions of any sleep disorder in the last 6 months or current complaints of sleep disturbance, irregular sleep schedule or shift work; habitual daytime naps; travel across time zones in the last 4 weeks or daytime symptoms attributable to unsatisfactory sleep
Has a history of or current major or clinically relevant psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) (example, mood, anxiety disorders, psychotic disorder et cetera)
Has had a clinically significant acute illness within 7 days prior to study intervention administration
Has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 48 participants (actual)

Study arms

Experimental
Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind)
Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8.
Drug: JNJ-69095897 · Other: Placebo
Experimental
Part 2: Single Dose Cohort (Open-label)
Healthy male participants will receive JNJ-69095897 orally in Cohort 9.
Drug: JNJ-69095897
Experimental
Part 3: Single or Divided Dose Cohort (Double-blind)
Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10.
Drug: JNJ-69095897 · Other: Placebo

Interventions

DrugJNJ-69095897
JNJ-69095897 will be administered orally in Parts 1, 2 and 3.
OtherPlacebo
Matching placebo will be administered orally in Parts 1 and 3.

What researchers measure

Primary outcomes

Number of Participants with Vital Sign Abnormalities
Number of participants with vital sign abnormalities including heart/pulse rate, systolic blood pressure, diastolic blood pressure, tympanic body temperature and respiratory rate will be reported.
Time frame: Up to Day 14
Number of Participants with Clinical Laboratory Abnormalities (Chemistry, Hematology, Urinalysis)
Number of participants with clinical laboratory abnormalities including chemistry, hematology and urinalysis will be reported.
Time frame: Up to Day 14
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 Day 14
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with ECG abnormalities will be reported.
Time frame: Up to Day 14
Number of Participants with Holter Recording Abnormalities
Number of participants with Holter recording abnormalities (including heart rate variability \[HRV\]) will be reported.
Time frame: Up to Day 2
Plasma Concentration of JNJ-69095897 and its Possible Metabolites
Plasma concentration of JNJ-69095897 and its possible metabolites will be reported.
Time frame: Up to Day 14
Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites
CSF concentration of JNJ-69095897 and its possible metabolites will be reported.
Time frame: Up to Day 2
Part 1: Urine Concentration of JNJ-69095897 and its Possible Metabolites
Urine concentration of JNJ-69095897 and its possible metabolites will be reported.
Time frame: Up to Day 4

Secondary outcomes

Plasma and CSF Concentration of Endogenous Metabolites
Plasma and CSF concentrations of endogenous metabolites will be reported.
Time frame: Day 1

Study locations

1 site

Centre for Human Drug Research
Leiden, 2333 CL, Netherlands

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: NCT04920578
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Jun 10, 2021
Start date: Jun 16, 2021
Primary completion: Jan 27, 2023
Completion: Feb 27, 2023
Last update: Apr 27, 2025

Study contacts

Jannsen Research & Development, LLC Clinical Trial

study director · Jannsen Research & Development, LLC

Oversight

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

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Janssen Research & Development, LLC

Start the discussion