HealthyPhase 1NCT03180762
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Participants
A Phase 1 study testing JNJ-64140284 0.1 mg, JNJ-64140284 0.5 mg and JNJ-64140284 2.5 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose… 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-64140284 0.1 mg, JNJ-64140284 0.5 mg and JNJ-64140284 2.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 30 May 2017to 25 Sep 2017
- 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
- Part 1 and 2:
- Healthy male participants between 18 and 58 years of age, inclusive
- Part 1, 2 and 3:
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase. 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 according to both the investigator and to the Janssen Safety Physician, are acceptable
- Part 3:
- Healthy male and female participants between 59 and 75 years of age, inclusive
- Participants must be healthy and medically stable on the basis of clinical laboratory tests (at screening) and physical and neurological examination (at screening and at admission to the clinical unit). If the participant is medically stable with medication, inclusion can be allowed on a case by case basis with written agreement of the sponsor's responsible safety physician
- Women must not be of childbearing potential (must be postmenopausal with amenorrhea for at least 12 months) or permanently sterilized (for example, tubal occlusion, hysterectomy, bilateral salpingectomy)
Who cannot join
- Part 1, 2 and 3:
- Participants with a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
- Participants with a serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
- Participants with a clinically significant acute illness within 7 days prior to study drug administration
- Donation of 1 or more units (approximately 450 milliliter [mL]) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration
- Part 3:
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- participants having a contraindication for spinal puncture including:
- A relevant history of lower back pain or scoliosis or kyphosis and/or major (lumbar) back surgery (microdiscectomy is allowed) in the opinion of the investigator
- Allergy to local anesthetics and/or iodine/disinfectants
- Clinically significant abnormal values for coagulation at screening
- Use of aspirin (even low dose) within 5 days prior to lumbar puncture
- Use of low molecular weight heparin (LMWH) within 12 hours prior to lumbar puncture
- Use of any anticoagulant treatment (besides LMWH described above) within 1 week prior to lumbar puncture
- Has a topical infection or local dermatological condition at the puncture site prior to puncture
- Has papilloedema or signs of increased intracranial pressure based on fundoscopy at screening
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-64140284 in Healthy Subjects
The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose administration.
- Conditions
- Healthy
- Being tested
- JNJ-64140284 0.1 mg, JNJ-64140284 0.5 mg, JNJ-64140284 2.5 mg, JNJ-64140284 10 mg, JNJ-64140284 50 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64140284 0.1 mgDrug
0.1 mg of JNJ-64140284 will be administered as an oral solution.
JNJ-64140284 0.5 mgDrug
0.5 mg of JNJ-64140284 will be administered as an oral solution.
JNJ-64140284 2.5 mgDrug
2.5 mg of JNJ-64140284 will be administered as an oral solution.
JNJ-64140284 10 mgDrug
10 mg of JNJ-64140284 will be administered as an oral solution.
JNJ-64140284 50 mgDrug
50 mg of JNJ-64140284 will be administered as an oral solution.
JNJ-64140284 150 mgDrug
150 mg of JNJ-64140284 will be administered as an oral solution.
JNJ-64140284 (dose to be determined [TBD])Drug
JNJ-64140284 (dose to be determined) will be administered as an oral solution.
PlaceboDrug
Matching placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 (JNJ-64140284 or Placebo) | Experimental | Participants will receive 0.1 milligram (mg) JNJ-64140284 or matching placebo under fasted condition on Day 1. Receives: Drug: JNJ-64140284 0.1 mg; Drug: Placebo |
| Part 1: Cohort 2 (JNJ-64140284 or Placebo) | Experimental | Participants will receive 0.5 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. Receives: Drug: JNJ-64140284 0.5 mg; Drug: Placebo |
| Part 1: Cohort 3 (JNJ-64140284 or Placebo) | Experimental | Participants will receive 2.5 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. Receives: Drug: JNJ-64140284 2.5 mg; Drug: Placebo |
| Part 1: Cohort 4 (JNJ-64140284 or Placebo) | Experimental | Participants will receive 10 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. Receives: Drug: JNJ-64140284 10 mg; Drug: Placebo |
| Part 1: Cohort 5 (JNJ-64140284 or Placebo) | Experimental | Participants will receive 50 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. Receives: Drug: JNJ-64140284 50 mg; Drug: Placebo |
| Part 1: Cohort 6 (JNJ-64140284 or Placebo) | Experimental | Participants will receive 150 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. Receives: Drug: JNJ-64140284 150 mg; Drug: Placebo |
| Part 2: Cohort 7 (JNJ-64140284) | Experimental | Participants will receive JNJ-64140284 (dose to be determined - the dose of JNJ-64140284 will be determined on the basis of acceptable safety, tolerability and pharmacokinetics [PK] of preceding dose levels; no more than 50 percent (%) of the highest dose tested [though as high as possible within this restriction] and considered well tolerated in Part 1) under fed conditions on Day 1. Receives: Drug: JNJ-64140284 (dose to be determined [TBD]) |
| Part 3: Cohort 8 (JNJ-64140284 or Placebo) | Experimental | Participants will receive JNJ-64140284 or matching placebo (dose to be determined - dose will be determined based on PK data from previous cohorts and which will be well-tolerated in Part 1) under fasted condition on Day 1. Receives: Drug: JNJ-64140284 (dose to be determined [TBD]); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3
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: Approximately 40 days
Maximum Plasma Concentration (Cmax) of JNJ-64140284: Part 1, Part 2, and Part 3
The Cmax is the maximum observed plasma concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Maximum Cerebrospinal Fluid (CSF) Concentration (Cmax) of JNJ-64140284: Part 3
The Cmax is the maximum observed CSF concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Last Quantifiable Plasma Concentration (Clast) of JNJ-64140284: Part 1, Part 2, and Part 3
The Clast is the last quantifiable plasma concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Last Quantifiable CSF Concentration (Clast) of JNJ-64140284: Part 3
The Clast is the last quantifiable CSF concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-64140284: Part 1, Part 2, and Part 3
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Time to Reach Maximum CSF Concentration (Tmax) of JNJ-64140284: Part 1, Part 2, and Part 3
The Tmax is defined as actual sampling time to reach maximum observed CSF concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-64140284: Part 1, Part 2, and Part 3
The Tlast is defined as the time of the last quantifiable plasma concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Time of the Last Quantifiable CSF Concentration (Tlast) of JNJ-64140284: Part 3
The Tlast is defined as the time of the last quantifiable CSF concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-64140284: Part 1, Part 2, and Part 3
The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Area Under the CSF Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-64140284: Part 1, Part 2, and Part 3
The (AUC [0-last]) is the area under the CSF concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64140284: Part 1, Part 2, and Part 3
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Area Under the CSF Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64140284: Part 3
The AUC (0-infinity) is the area under the CSF concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the CSF concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
Elimination Rate Constant (Lambda[z]) of JNJ-64140284: Part 1, Part 2, and Part 3
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Elimination Half-life (t1/2) of JNJ-64140284: Part 1, Part 2, and Part 3
The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Total Clearance (CL/F) of JNJ-64140284: Part 1, Part 2, and Part 3
CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Creatinine Clearance (CLcr) of JNJ-64140284: Part 1, Part 2, and Part 3
CLcr will be determined with the Cockcroft-Gault formula.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Amount of Drug Excreted in Urine From Time Zero to Infinite Time (Aeinf): Part 1
Aeinf is the cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity.
Measured: 0-1, 1-2, 2-4, 4-12, and 12-24 hours post dose
Renal Clearance (CLr): Part 1
The CLr is the renal clearance of the drug.
Measured: 0-1, 1-2, 2-4, 4-12, and 12-24 hours post dose
Secondary outcomes (15)
Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 3
The VAS is a participant rated scale, made up of 16 (items) pairs of alternative descriptors of mood and attention at either end of a 10 cm line. The item score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Measured: Days -1, 1, 2 and 3
Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 3
The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep' (9).
Measured: Days -1, 1, 2 and 3
Profile of Mood States (POMS) Score: Part 1 and Part 3
The POMS is a self-administered scale that assesses individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items describing the feeling/mood state rated by participants on a 5-point scale (where, 0=not at all and 4=extremely). The greater the score, the greater the corresponding mood state.
Measured: Days -1, 1, 2 and 3
Body Sway: Part 1
Body sway will be used to measure body movements, providing a measure of postural stability. The method has been used to demonstrate effects of sleep deprivation, alcohol, and benzodiazepines. It will be measured either using a stabilometric platform or a pot string meter based on the Wright ataxiameter.
Measured: Days -1, 1, 2 and 3
Cognitive Test Battery: International Shopping List Test (ISLT): Part 1
The ISLT is a measure of Verbal Learning. The test measures total number of correct responses remembering the word list on 3 consecutive trials at a single assessment. Higher score indicates better performance.
Measured: Days -21 to -2, Day -1, and Day 1 (6 hours post dose)
Cognitive Test Battery: Groton Maze Learning Test (GMLT): Part 1
GMLT is a measure of Executive Function and Spatial Learning. The test measures total number of errors made while locating and learning 28 step pathway hidden beneath a 10*10 grid on 5 consecutive trials during a single session. Lower score indicates better performance.
Measured: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: Detection Task (DET): Part 1
DET is a measure of Psychomotor Function. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.
Measured: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: Identification Task (IDN): Part 1
IDN is a measure of Attention. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.
Measured: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: One Card Learning Task (OCL): Part 1
OCL is a measure of Visual Learning. The test measures accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Higher score indicates better performance.
Measured: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: One Back Task (ONB): Part 1
ONB is a measure of Working Memory. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.
Measured: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: Groton Maze Learning Test (GMLT) Delayed Recall: Part 1
GMLT delayed recall is a measure of Delayed Spatial Memory. The test measures number of errors made while locating 28 step pathway hidden beneath a 10*10 grid after a delay. Lower score indicates better performance.
Measured: Days -21 to -2, Day -1, and Day 1 (6 hours post dose)
Cognitive Test Battery: International Shopping List Test Delayed (ISLT-D): Part 1
ISLT-D is a measure of Delayed Verbal Memory. The test measures total number of correct responses recalling the word list learned initially. Higher score indicates better performance.
Measured: Days -21 to -2, Day -1, Predose, Day 1 (6 hours post dose), and Day 2 (24 hours post dose)
Sheehan Irritability Scale (SIS) Score: Part 1 and Part 3
The SIS is a 7-item self-report rating scale that assess symptoms of irritability, frustration, edginess/impatience, moodiness, anger with self, anger with others and temper during the past hour. Each item is assessed on an 11-point numeric rating scale ranging from 0 (not at all) to 10 (extremely). The SIS total score is calculated by summing of the scores for each of the 7 individual items and ranges from 0 to 70. A higher score indicates greater symptomatology.
Measured: Day -1, Day 1 (6 and 12 hours post dose), and Day 2 (24 hours post dose)
Cerebrospinal Fluid (CSF) Biomarkers Level: Brain Derived Neurotrophic Factor (BDNF): Part 3
BDNF level in the CSF (a CSF biomarker) will be analyzed to evaluate the pharmacodynamic effect of JNJ-64140284.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post dose
Cerebrospinal Fluid (CSF) Biomarkers Level: Monoaminergic Neurotransmitters and Their Metabolites: Part 3
Monoaminergic neurotransmitters (such as dopamine, serotonine and [nor]adrenaline) and their metabolites (such as homovanillic acid [HVA], 3,4-dihydroxyphenyl glycol [DHPG], 5-hydroxyindoleacetic acid [5-HIAA], 3,4-dihydroxyphenylalanine [DOPA], and 3,4-dihydroxyphenylacetic acid [DOPAC]) in the CSF (CSF biomarkers) will be analyzed to evaluate the pharmacodynamic effect of JNJ-64140284.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start30 May 2017
- Primary completion25 Sep 2017
- Study completion25 Sep 2017
Why it stopped: Trial stopped: A SAE has occured. As a measure of precaution, the trial has been stopped.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT03180762
- Sponsor's protocol ID
- CR108318
- Other IDs
- 2017-000283-16, 64140284EDI1001, 2017
- Status last verified
- Oct 2018
- First submitted
- 30 May 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. 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-64140284 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03180762
- Acronym / sponsor ID
- CR108318
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial stopped: A SAE has occured. As a measure of precaution, the trial has been stopped.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 8 Jun 2017 (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-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 0.1 mg, Drug: PlaceboParticipants will receive 0.1 milligram (mg) JNJ-64140284 or matching placebo under fasted condition on Day 1. |
| Part 1: Cohort 2 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 0.5 mg, Drug: PlaceboParticipants will receive 0.5 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. |
| Part 1: Cohort 3 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 2.5 mg, Drug: PlaceboParticipants will receive 2.5 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. |
| Part 1: Cohort 4 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 10 mg, Drug: PlaceboParticipants will receive 10 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. |
| Part 1: Cohort 5 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 50 mg, Drug: PlaceboParticipants will receive 50 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. |
| Part 1: Cohort 6 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 150 mg, Drug: PlaceboParticipants will receive 150 mg JNJ-64140284 or matching placebo under fasted condition on Day 1. |
| Part 2: Cohort 7 (JNJ-64140284) | Experimental | Drug: JNJ-64140284 (dose to be determined [TBD])Participants will receive JNJ-64140284 (dose to be determined - the dose of JNJ-64140284 will be determined on the basis of acceptable safety, tolerability and pharmacokinetics [PK] of preceding dose levels; no more than 50 percent (%) of the highest dose tested [though as high as possible within this restriction] and considered well tolerated in Part 1) under fed conditions on Day 1. |
| Part 3: Cohort 8 (JNJ-64140284 or Placebo) | Experimental | Drug: JNJ-64140284 (dose to be determined [TBD]), Drug: PlaceboParticipants will receive JNJ-64140284 or matching placebo (dose to be determined - dose will be determined based on PK data from previous cohorts and which will be well-tolerated in Part 1) under fasted condition on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male participants between 18 and 58 years of age, inclusive
- Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase. 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 according to both the investigator and to the Janssen Safety Physician, are acceptable
- Healthy male and female participants between 59 and 75 years of age, inclusive
- Participants must be healthy and medically stable on the basis of clinical laboratory tests (at screening) and physical and neurological examination (at screening and at admission to the clinical unit). If the participant is medically stable with medication, inclusion can be allowed on a case by case basis with written agreement of the sponsor's responsible safety physician
- Women must not be of childbearing potential (must be postmenopausal with amenorrhea for at least 12 months) or permanently sterilized (for example, tubal occlusion, hysterectomy, bilateral salpingectomy)
Key exclusion criteria (15 listed)
- Participants with a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
- Participants with a serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
- Participants with a clinically significant acute illness within 7 days prior to study drug administration
- Donation of 1 or more units (approximately 450 milliliter [mL]) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration
- participants having a contraindication for spinal puncture including:
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-64140284 0.1 mg0.1 mg of JNJ-64140284 will be administered as an oral solution. | Drug | Part 1: Cohort 1 (JNJ-64140284 or Placebo) |
| JNJ-64140284 0.5 mg0.5 mg of JNJ-64140284 will be administered as an oral solution. | Drug | Part 1: Cohort 2 (JNJ-64140284 or Placebo) |
| JNJ-64140284 2.5 mg2.5 mg of JNJ-64140284 will be administered as an oral solution. | Drug | Part 1: Cohort 3 (JNJ-64140284 or Placebo) |
| JNJ-64140284 10 mg10 mg of JNJ-64140284 will be administered as an oral solution. | Drug | Part 1: Cohort 4 (JNJ-64140284 or Placebo) |
| JNJ-64140284 50 mg50 mg of JNJ-64140284 will be administered as an oral solution. | Drug | Part 1: Cohort 5 (JNJ-64140284 or Placebo) |
| JNJ-64140284 150 mg150 mg of JNJ-64140284 will be administered as an oral solution. | Drug | Part 1: Cohort 6 (JNJ-64140284 or Placebo) |
| JNJ-64140284 (dose to be determined [TBD])JNJ-64140284 (dose to be determined) will be administered as an oral solution. | Drug | Part 2: Cohort 7 (JNJ-64140284), Part 3: Cohort 8 (JNJ-64140284 or Placebo) |
| PlaceboMatching placebo will be administered. | Drug | Part 1: Cohort 1 (JNJ-64140284 or Placebo), Part 1: Cohort 2 (JNJ-64140284 or Placebo), Part 1: Cohort 3 (JNJ-64140284 or Placebo), Part 1: Cohort 4 (JNJ-64140284 or Placebo), Part 1: Cohort 5 (JNJ-64140284 or Placebo), Part 1: Cohort 6 (JNJ-64140284 or Placebo), Part 3: Cohort 8 (JNJ-64140284 or Placebo) |
Primary outcome
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3
Time frame: Approximately 40 days
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.
Maximum Plasma Concentration (Cmax) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
The Cmax is the maximum observed plasma concentration.
Maximum Cerebrospinal Fluid (CSF) Concentration (Cmax) of JNJ-64140284: Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
The Cmax is the maximum observed CSF concentration.
Last Quantifiable Plasma Concentration (Clast) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
The Clast is the last quantifiable plasma concentration.
Last Quantifiable CSF Concentration (Clast) of JNJ-64140284: Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
The Clast is the last quantifiable CSF concentration.
Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Time to Reach Maximum CSF Concentration (Tmax) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
The Tmax is defined as actual sampling time to reach maximum observed CSF concentration.
Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
The Tlast is defined as the time of the last quantifiable plasma concentration.
Time of the Last Quantifiable CSF Concentration (Tlast) of JNJ-64140284: Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
The Tlast is defined as the time of the last quantifiable CSF concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Area Under the CSF Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
The (AUC [0-last]) is the area under the CSF concentration-time curve from time 0 to time of the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Area Under the CSF Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64140284: Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose
The AUC (0-infinity) is the area under the CSF concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the CSF concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Elimination Rate Constant (Lambda[z]) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Elimination Half-life (t1/2) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Total Clearance (CL/F) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability.
Creatinine Clearance (CLcr) of JNJ-64140284: Part 1, Part 2, and Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose
CLcr will be determined with the Cockcroft-Gault formula.
Amount of Drug Excreted in Urine From Time Zero to Infinite Time (Aeinf): Part 1
Time frame: 0-1, 1-2, 2-4, 4-12, and 12-24 hours post dose
Aeinf is the cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity.
Renal Clearance (CLr): Part 1
Time frame: 0-1, 1-2, 2-4, 4-12, and 12-24 hours post dose
The CLr is the renal clearance of the drug.
15 secondary outcomes
Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 3
Time frame: Days -1, 1, 2 and 3
Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 3
Time frame: Days -1, 1, 2 and 3
Profile of Mood States (POMS) Score: Part 1 and Part 3
Time frame: Days -1, 1, 2 and 3
Body Sway: Part 1
Time frame: Days -1, 1, 2 and 3
Cognitive Test Battery: International Shopping List Test (ISLT): Part 1
Time frame: Days -21 to -2, Day -1, and Day 1 (6 hours post dose)
Cognitive Test Battery: Groton Maze Learning Test (GMLT): Part 1
Time frame: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: Detection Task (DET): Part 1
Time frame: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: Identification Task (IDN): Part 1
Time frame: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: One Card Learning Task (OCL): Part 1
Time frame: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: One Back Task (ONB): Part 1
Time frame: Days -21 to -2, Day -1, Day 1 (2, 4, 6, and 12 hours post dose), and Day 2 (24 hours post dose)
Cognitive Test Battery: Groton Maze Learning Test (GMLT) Delayed Recall: Part 1
Time frame: Days -21 to -2, Day -1, and Day 1 (6 hours post dose)
Cognitive Test Battery: International Shopping List Test Delayed (ISLT-D): Part 1
Time frame: Days -21 to -2, Day -1, Predose, Day 1 (6 hours post dose), and Day 2 (24 hours post dose)
Sheehan Irritability Scale (SIS) Score: Part 1 and Part 3
Time frame: Day -1, Day 1 (6 and 12 hours post dose), and Day 2 (24 hours post dose)
Cerebrospinal Fluid (CSF) Biomarkers Level: Brain Derived Neurotrophic Factor (BDNF): Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post dose
Cerebrospinal Fluid (CSF) Biomarkers Level: Monoaminergic Neurotransmitters and Their Metabolites: Part 3
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post dose
Results and safety
The study was stopped early (reason given: Trial stopped: A SAE has occured. As a measure of precaution, the trial has been stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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-64140284 0.1 mg, JNJ-64140284 0.5 mg and JNJ-64140284 2.5 mg 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 8 inclusion and 15 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 30 Oct 2018. 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 was stopped early (reason given: Trial stopped: A SAE has occured. As a measure of precaution, the trial has been stopped.). 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 Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3 (time frame: Approximately 40 days). The study lists 19 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 30 Oct 2018.