Clinical trial NCT04566926: A Study of JNJ-64140284 in Healthy Male Participants
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Plasma Concentration of JNJ-64140284
timeFrame: Pre-dose, Day 1, 2, 3 and Day 4
measure: Part 1: Urine Concentration of JNJ-64140284
timeFrame: Pre-dose, Day 1, 2, 3 and Day 4
measure: Part 2: Plasma Concentration After Single Dose Administration of JNJ-64140284
timeFrame: Pre-dose, Day 1, 2, 3 and Day 4
measure: Part 3: Ratio of Area Under Plasma Concentration Curve (AUC) and Maximum Plasma Concentration (Cmax)
timeFrame: Pre-dose, Day 1, 2, 3 and Day 4
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3
timeFrame: Up to 1.5 years
Secondary outcomes:
measure: Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2
timeFrame: Day -1, 1, 2 and Day 3
measure: Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2
timeFrame: Day -1, 1, 2 and Day 3
measure: Body Sway
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: One Card Learning Task (OCL)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: One Back Task (ONB)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test (GMLT)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test (ISLT)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test delayed (ISLT-D)
timeFrame: Day -1, 1, 2 and Day 3
measure: Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test delayed (GMLT-D)
timeFrame: Day -1, 1, 2 and Day 3
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Life Science Services
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: