HealthyPhase 1NCT04920578
A Study of JNJ-69095897 in Healthy Participants
A Phase 1 study testing JNJ-69095897 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-69095897
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jun 2021to 27 Feb 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-69095897 in Healthy Participants
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
- Healthy
- Being tested
- JNJ-69095897, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-69095897Drug
JNJ-69095897 will be administered orally in Parts 1, 2 and 3.
PlaceboOther
Matching placebo will be administered orally in Parts 1 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind) | Experimental | Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8. Receives: Drug: JNJ-69095897; Other: Placebo |
| Part 2: Single Dose Cohort (Open-label) | Experimental | Healthy male participants will receive JNJ-69095897 orally in Cohort 9. Receives: Drug: JNJ-69095897 |
| Part 3: Single or Divided Dose Cohort (Double-blind) | Experimental | Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10. Receives: Drug: JNJ-69095897; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 14
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with ECG abnormalities will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 4
Secondary outcomes (1)
Plasma and CSF Concentration of Endogenous Metabolites
Plasma and CSF concentrations of endogenous metabolites will be reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start16 Jun 2021
- Primary completion27 Jan 2023
- Study completion27 Feb 2023
Why it stopped: business decision to end clinical development of JNJ-69095897
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jannsen Research & Development, LLC Clinical Trial, Study director, Jannsen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920578
- Sponsor's protocol ID
- CR108935
- Other IDs
- 2021-000609-26, 69095897EDI1001
- Status last verified
- Apr 2025
- First submitted
- 8 Jun 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
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 3-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-69095897 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04920578
- Acronym / sponsor ID
- CR108935
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business decision to end clinical development of JNJ-69095897
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 10 Jun 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind) | Experimental | Drug: JNJ-69095897, Other: PlaceboHealthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8. |
| Part 2: Single Dose Cohort (Open-label) | Experimental | Drug: JNJ-69095897Healthy male participants will receive JNJ-69095897 orally in Cohort 9. |
| Part 3: Single or Divided Dose Cohort (Double-blind) | Experimental | Drug: JNJ-69095897, Other: PlaceboHealthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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-69095897JNJ-69095897 will be administered orally in Parts 1, 2 and 3. | Drug | Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind), Part 2: Single Dose Cohort (Open-label), Part 3: Single or Divided Dose Cohort (Double-blind) |
| PlaceboMatching placebo will be administered orally in Parts 1 and 3. | Other | Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind), Part 3: Single or Divided Dose Cohort (Double-blind) |
Primary outcome
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 14
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.
Number of Participants with Clinical Laboratory Abnormalities (Chemistry, Hematology, Urinalysis)
Time frame: Up to Day 14
Number of participants with clinical laboratory abnormalities including chemistry, hematology and urinalysis will be reported.
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 14
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 Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 14
Number of participants with ECG abnormalities will be reported.
Number of Participants with Holter Recording Abnormalities
Time frame: Up to Day 2
Number of participants with Holter recording abnormalities (including heart rate variability [HRV]) will be reported.
Plasma Concentration of JNJ-69095897 and its Possible Metabolites
Time frame: Up to Day 14
Plasma concentration of JNJ-69095897 and its possible metabolites will be reported.
Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites
Time frame: Up to Day 2
CSF concentration of JNJ-69095897 and its possible metabolites will be reported.
Part 1: Urine Concentration of JNJ-69095897 and its Possible Metabolites
Time frame: Up to Day 4
Urine concentration of JNJ-69095897 and its possible metabolites will be reported.
1 secondary outcome
Plasma and CSF Concentration of Endogenous Metabolites
Time frame: Day 1
Results and safety
The study was stopped early (reason given: business decision to end clinical development of JNJ-69095897). Results are not available in the source record.
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.
Jannsen Research & Development, LLC Clinical Trial study director
Jannsen 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-69095897 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
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: stopped early, 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 Netherlands. 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 was stopped early (reason given: business decision to end clinical development of JNJ-69095897). Results are not available in the source record.
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 Vital Sign Abnormalities (time frame: Up to Day 14). 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?
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.