HealthyPhase 1NCT02933762
A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
A Phase 1 study testing JNJ-54175446 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of… 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-54175446
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Nov 2016
- 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
- Participants must have a body mass index (BMI) between 18 and 32 kilogram (kg)/ meter (m)^2, inclusive (BMI = weight/height^2)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)
- Part 1 and 2 (Elderly Participants):
- Healthy male or female participants between 55 and 75 years of age, inclusive
- Participant must be healthy on the basis of both physical and neurological examination performed at Screening and at admission to the clinical unit
- Part 1 (Young Participants):
- Healthy male participants between 18 and 45 years of age, inclusive
Who cannot join
- Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening (per Screening evaluations)
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per Screening evaluations)
- Participant has a history of malignancy within 5 years before Screening
- Participant has signs of increased intracranial pressure based on fundoscopy at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Single-Blind, Placebo-Controlled, Randomized, Single- and Multiple-Dose Pharmacodynamics Study in Healthy Subjects to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.
- Conditions
- Healthy
- Being tested
- JNJ-54175446, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54175446Drug
Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.
PlaceboDrug
Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg]) | Experimental | Healthy elderly participants will receive single dose of 30mg JNJ-54175446. Receives: Drug: JNJ-54175446 |
| Part 1: Cohort A1 (JNJ-54175446 100mg) | Experimental | Healthy elderly participants will receive single dose of 100mg JNJ-54175446. Receives: Drug: JNJ-54175446 |
| Part 1: Cohort A1 (JNJ-54175446 300mg) | Experimental | Healthy elderly participants will receive single dose of 300mg JNJ-54175446. Receives: Drug: JNJ-54175446 |
| Part 1: Cohort A1 (Placebo) | Experimental | Healthy elderly participants will receive single dose of placebo. Receives: Drug: Placebo |
| Part 1: Cohort A2 (JNJ-54175446 D1 mg) | Experimental | Healthy elderly participants will receive an additional dose D1 mg [less than or equal to (<=) 600 mg] of JNJ-54175446, to be determined. Receives: Drug: JNJ-54175446 |
| Part 1: Cohort A3 (JNJ-54175446 D2 mg) | Experimental | Healthy young participants will receive a single dose D2 mg (<= 600 mg) of JNJ-54175446, to be determined. Receives: Drug: JNJ-54175446 |
| Part 1: Cohort A3 (Placebo) | Experimental | Healthy young participants will receive a single dose of placebo. Receives: Drug: Placebo |
| Part 2: Cohort B1 (JNJ-54175446 D3 mg) | Experimental | Healthy elderly participants will receive multiple dose levels D3 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. Receives: Drug: JNJ-54175446 |
| Part 2: Cohort B1 (Placebo) | Experimental | Healthy elderly participants will receive placebo determined based on the results from Cohort A1. Receives: Drug: Placebo |
| Part 2: Cohort B2 (JNJ-54175446 D4 mg) | Experimental | Healthy elderly participants will receive multiple dose levels D4 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. Receives: Drug: JNJ-54175446 |
| Part 2: Cohort B2 (Placebo) | Experimental | Healthy elderly participants will receive placebo determined based on the results from Cohort A1 Receives: Drug: Placebo |
| Part 2: Cohort B3 (JNJ-54175446 D5 mg) | Experimental | Healthy elderly participants will receive multiple dose levels D5 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. Receives: Drug: JNJ-54175446 |
| Part 2: Cohort B3 (Placebo) | Experimental | Healthy elderly participants will receive placebo determined based on the results from Cohort A1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Measured: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Measured: Part 2: Up to Day 8
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Measured: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Measured: Part 2: Up to Day 8
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Measured: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Measured: Part 2: Up to Day 8
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Measured: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Measured: Part 2: Up to Day 8
Maximum Observed Plasma Concentration (Cmax) After Single- and Multiple-Dose Administration
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Minimum Observed Plasma Concentration (Cmin)During Dosing Interval
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
The Observed Plasma Concentration Just Prior to the Beginning or at the end of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
Measured: Part 1: Day 1 - Day 2; Par 2: Day 1, Day 2 to 6, Day 7, Day 8
Time to Reach the Maximum Plasma Concentration, After Single- and Multiple-Dose Administration (Tmax)
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Area Under The Concentration-Time Curve From 0 To t Hours Postdosing (AUCt)
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Area Under the Concentration-Time Curve From 0 to 24 Hours Postdosing (AUC24h)
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
The Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration (Peak/Trough Ratio)
Measured: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Screening up to follow-up (in part 1 and part 2 [approximately up to 8 weeks])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933762
- Sponsor's protocol ID
- CR108231
- Other IDs
- 2016-003040-37, 54175446EDI1005, 2016
- Status last verified
- Jan 2025
- First submitted
- 21 Sep 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Triana-Baltzer G, Timmers M, De Boer P, Schoene M, Furey M, Bleys C, Vrancken I, Slemmon R, Ceusters M, van Nueten L, Kolb H. Profiling classical neuropsychiatric biomarkers across biological fluids and following continuous lumbar puncture: A guide to sample type and time. Compr Psychoneuroendocrinol. 2022 Jan 15;10:100116. doi: 10.1016/j.cpnec.2022.100116. eCollection 2022 May.
PubMed 35774109
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-Blind, Placebo-Controlled, Randomized, Single- and Multiple-Dose Pharmacodynamics Study in Healthy Subjects to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
- ClinicalTrials.gov ID
- NCT02933762
- Acronym / sponsor ID
- CR108231
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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 primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg]) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive single dose of 30mg JNJ-54175446. |
| Part 1: Cohort A1 (JNJ-54175446 100mg) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive single dose of 100mg JNJ-54175446. |
| Part 1: Cohort A1 (JNJ-54175446 300mg) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive single dose of 300mg JNJ-54175446. |
| Part 1: Cohort A1 (Placebo) | Experimental | Drug: PlaceboHealthy elderly participants will receive single dose of placebo. |
| Part 1: Cohort A2 (JNJ-54175446 D1 mg) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive an additional dose D1 mg [less than or equal to (<=) 600 mg] of JNJ-54175446, to be determined. |
| Part 1: Cohort A3 (JNJ-54175446 D2 mg) | Experimental | Drug: JNJ-54175446Healthy young participants will receive a single dose D2 mg (<= 600 mg) of JNJ-54175446, to be determined. |
| Part 1: Cohort A3 (Placebo) | Experimental | Drug: PlaceboHealthy young participants will receive a single dose of placebo. |
| Part 2: Cohort B1 (JNJ-54175446 D3 mg) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive multiple dose levels D3 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. |
| Part 2: Cohort B1 (Placebo) | Experimental | Drug: PlaceboHealthy elderly participants will receive placebo determined based on the results from Cohort A1. |
| Part 2: Cohort B2 (JNJ-54175446 D4 mg) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive multiple dose levels D4 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. |
| Part 2: Cohort B2 (Placebo) | Experimental | Drug: PlaceboHealthy elderly participants will receive placebo determined based on the results from Cohort A1 |
| Part 2: Cohort B3 (JNJ-54175446 D5 mg) | Experimental | Drug: JNJ-54175446Healthy elderly participants will receive multiple dose levels D5 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. |
| Part 2: Cohort B3 (Placebo) | Experimental | Drug: PlaceboHealthy elderly participants will receive placebo determined based on the results from Cohort A1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have a body mass index (BMI) between 18 and 32 kilogram (kg)/ meter (m)^2, inclusive (BMI = weight/height^2)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)
- Healthy male or female participants between 55 and 75 years of age, inclusive
- Participant must be healthy on the basis of both physical and neurological examination performed at Screening and at admission to the clinical unit
- Healthy male participants between 18 and 45 years of age, inclusive
Key exclusion criteria (5 listed)
- Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening (per Screening evaluations)
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per Screening evaluations)
- Participant has a history of malignancy within 5 years before Screening
- Participant has signs of increased intracranial pressure based on fundoscopy at Screening
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-54175446Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2. | Drug | Part 1: Cohort A1 (JNJ-54175446 100mg), Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg]), Part 1: Cohort A1 (JNJ-54175446 300mg), Part 1: Cohort A2 (JNJ-54175446 D1 mg), Part 1: Cohort A3 (JNJ-54175446 D2 mg), Part 2: Cohort B1 (JNJ-54175446 D3 mg), Part 2: Cohort B2 (JNJ-54175446 D4 mg), Part 2: Cohort B3 (JNJ-54175446 D5 mg) |
| PlaceboParticipants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2. | Drug | Part 1: Cohort A1 (Placebo), Part 1: Cohort A3 (Placebo), Part 2: Cohort B1 (Placebo), Part 2: Cohort B2 (Placebo), Part 2: Cohort B3 (Placebo) |
Primary outcome
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Time frame: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma
Time frame: Part 2: Up to Day 8
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Time frame: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF)
Time frame: Part 2: Up to Day 8
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Time frame: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood
Time frame: Part 2: Up to Day 8
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Time frame: Part 1: Up to Day 2
The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF
Time frame: Part 2: Up to Day 8
Maximum Observed Plasma Concentration (Cmax) After Single- and Multiple-Dose Administration
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Minimum Observed Plasma Concentration (Cmin)During Dosing Interval
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
The Observed Plasma Concentration Just Prior to the Beginning or at the end of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
Time frame: Part 1: Day 1 - Day 2; Par 2: Day 1, Day 2 to 6, Day 7, Day 8
Time to Reach the Maximum Plasma Concentration, After Single- and Multiple-Dose Administration (Tmax)
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Area Under The Concentration-Time Curve From 0 To t Hours Postdosing (AUCt)
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
Area Under the Concentration-Time Curve From 0 to 24 Hours Postdosing (AUC24h)
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
The Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration (Peak/Trough Ratio)
Time frame: Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Screening up to follow-up (in part 1 and part 2 [approximately up to 8 weeks])
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 3 Feb 2025.
- Derived from this study: PubMed 35774109Triana-Baltzer G, Timmers M, De Boer P, Schoene M, Furey M, Bleys C, Vrancken I, Slemmon R, Ceusters M, van Nueten L, Kolb H. Profiling classical neuropsychiatric biomarkers across biological fluids and following continuous lumbar puncture: A guide to sample type and time. Compr Psychoneuroendocrinol. 2022 Jan 15;10:100116. doi: 10.1016/j.cpnec.2022.100116. eCollection 2022 May.
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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-54175446 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 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: finished, as of the sponsor's last update on 3 Feb 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. 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?
The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma (time frame: Part 1: Up to Day 2). The study lists 16 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 NCT02933762, which also lists 1 linked publication.
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 3 Feb 2025.