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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002616-40 | EudraCT Number | ||
| 64140284EDI1005 | Other Identifier | Janssen Pharmaceutica N.V., Belgium |
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The purpose of the study is to investigate and compare the pharmacokinetic (PK) profiles of a single dose of two solid dosage formulations of JNJ-64140284 in plasma and urine in healthy male participants under fed and fasting conditions; and to investigate the safety and tolerability of two solid dosage formulations of JNJ 64140284 versus placebo after single oral dose administration in healthy male participants under fed and fasting conditions in Part 1; to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (or 1 divided dose, if applicable) (ascending dose levels) in healthy male participants; and to characterize the PK of a single dose (or 1 divided dose, if applicable) of JNJ-64140284 in plasma in healthy male participants in Part 2; and to investigate the effect of food on the PK of a single (or 1 divided dose, if applicable) therapeutic relevant dose of JNJ 64140284 in healthy male participants; and to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration at a therapeutic relevant dose (or 1 divided dose, if applicable) in fed conditions in Part 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 (Placebo or JNJ-64140284) | Experimental | Participants will receive matching placebo in Treatment A or JNJ-64140284 (as formulation 1) in Treatment B or JNJ-64140284 (as formulation 2) in Treatment C on Day 1 under fasted condition. Participants will receive treatment in either of the 6 treatment sequences (ABC, BCA, CAB, CBA, ACB or BAC) in Period 1, 2, or 3 under fasted condition. Each period is separated by washout period of 5 days. |
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| Part 1: Cohort 2 (Placebo or JNJ-64140284) | Experimental | Participants will receive matching placebo (Treatment D) or JNJ- 64140284 (as formulation 1) in Treatment E or JNJ-64140284 (as formulation 2) in Treatment F. Participants will receive treatment in either of 6 treatment sequence (DEF, EFD, FDE, FED, DFE or EDF) in Period 1, 2, or 3 under fed condition. Each period is separated by washout period of 5 days. |
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| Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo) | Experimental | Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1. |
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| Part 3: Cohorts 1-2 (JNJ-64140284 or placebo) | Experimental | Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64140284 | Drug | Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Plasma Concentration of JNJ-64140284 | Plasma samples will be analyzed to determine concentrations of JNJ-64140284 under fed and fasting conditions using a validated, specific and sensitive liquid chromatography-mass spectrometry (LC-MS/MS). | Pre-dose, Day 1, 2, 3 and Day 4 |
| Part 1: Urine Concentration of JNJ-64140284 | Urine samples will be analyzed to determine concentrations of JNJ-64140284 in renal clearance. | Pre-dose, Day 1, 2, 3 and Day 4 |
| Part 2: Plasma Concentration After Single Dose Administration of JNJ-64140284 | Plasma samples will be analyzed to determine concentrations of JNJ-64140284 under fed and fasting conditions using a validated, specific and sensitive liquid chromatography-mass spectrometry (LC-MS/MS). | Pre-dose, Day 1, 2, 3 and Day 4 |
| Part 3: Ratio of Area Under Plasma Concentration Curve (AUC) and Maximum Plasma Concentration (Cmax) | Ratio of geometric means for pharmacokinetics (PK) parameters (AUCs and Cmax) of JNJ 64140284 (fed versus fasted condition) will be analyzed to determine the food effect. | Pre-dose, Day 1, 2, 3 and Day 4 |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3 | An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. |
| Measure | Description | Time Frame |
|---|---|---|
| Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2 | 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-centimeter (cm) line. The item score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria. | Day -1, 1, 2 and Day 3 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium Clinical Trial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services | Antwerp | 2060 | Belgium |
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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| Placebo | Drug | Participant will receive matching placebo. |
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| Up to 1.5 years |
| Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2 | 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). | Day -1, 1, 2 and Day 3 |
| Body Sway | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: One Card Learning Task (OCL) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: One Back Task (ONB) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test (GMLT) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test (ISLT) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test delayed (ISLT-D) | 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. | Day -1, 1, 2 and Day 3 |
| Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test delayed (GMLT-D) | 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. | Day -1, 1, 2 and Day 3 |