A Study of JNJ-64140284 in Healthy Male Participants
- Registration Number
- NCT04566926
- Lead Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Cohort 2 (Placebo or JNJ-64140284) Placebo 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. Part 1: Cohort 1 (Placebo or JNJ-64140284) JNJ-64140284 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. Part 3: Cohorts 1-2 (JNJ-64140284 or placebo) Placebo Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1. Part 1: Cohort 1 (Placebo or JNJ-64140284) Placebo 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. Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo) JNJ-64140284 Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1. Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo) Placebo Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1. Part 1: Cohort 2 (Placebo or JNJ-64140284) JNJ-64140284 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. Part 3: Cohorts 1-2 (JNJ-64140284 or placebo) JNJ-64140284 Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1.
- Primary Outcome Measures
Name Time Method Part 1: Plasma Concentration of JNJ-64140284 Pre-dose, Day 1, 2, 3 and Day 4 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).
Part 3: Ratio of Area Under Plasma Concentration Curve (AUC) and Maximum Plasma Concentration (Cmax) Pre-dose, Day 1, 2, 3 and Day 4 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.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3 Up to 1.5 years 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.
Part 1: Urine Concentration of JNJ-64140284 Pre-dose, Day 1, 2, 3 and Day 4 Urine samples will be analyzed to determine concentrations of JNJ-64140284 in renal clearance.
Part 2: Plasma Concentration After Single Dose Administration of JNJ-64140284 Pre-dose, Day 1, 2, 3 and Day 4 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).
- Secondary Outcome Measures
Name Time Method Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2 Day -1, 1, 2 and Day 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-centimeter (cm) line. The item score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2 Day -1, 1, 2 and Day 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).
Body Sway Day -1, 1, 2 and Day 3 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.
Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: One Card Learning Task (OCL) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: One Back Task (ONB) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test (GMLT) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test (ISLT) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test delayed (ISLT-D) Day -1, 1, 2 and Day 3 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.
Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test delayed (GMLT-D) Day -1, 1, 2 and Day 3 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.
Trial Locations
- Locations (1)
SGS Life Science Services
🇧🇪Antwerpen, Belgium