A Study of JNJ-64140284 in Healthy Male Participants

Healthy Clinical Trial

— AMPAR  

Official title:

A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Male Participants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04566926
• Other study ID #: CR108866
• Secondary ID: 2020-002616-4064
• Status: Terminated
• Phase: Phase 1
• Start date: September 29, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2022
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

Inclusion criteria:

• Participant has a body mass index (BMI) between 18.0 and 29.9 kilograms per square meters (kg/m^2) inclusive

• Participant must be healthy on the basis of clinical laboratory tests. 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. 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. This determination must be recorded in the participant's source documents and initialed by the investigator

• Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) (means of triplicate ECG, incl. QTcF less than or equal to [<=] 450 milliseconds [msec] for males). Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable

• A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 3 months after receiving the last dose of study intervention

• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion criteria:

• Participant has 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

• Participant has a Left Bundle Branch Block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD)

• Participant has a history of suicidal ideation or a family history of suicide

• Participant has a history of major depressive disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64140284
Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.
• Placebo
Participant will receive matching placebo.

Locations

Country	Name	City	State
Belgium	SGS Life Science Services	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	Up to 1.5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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