A Study of JNJ-64140284 in Healthy Male Participants

NCT04566926 | Terminated Phase 1

• 3 other identifiers: CR1088662020-002616-4064140284EDI1005
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to 1.5 years

Secondary Outcomes (11)

• Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2

  Day -1, 1, 2 and Day 3

• Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2

  Day -1, 1, 2 and Day 3

• Body Sway

  Day -1, 1, 2 and Day 3

• Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET)

  Day -1, 1, 2 and Day 3

• Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN)

  Day -1, 1, 2 and Day 3

Study Arms (4)

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.

Drug: JNJ-64140284; Drug: Placebo

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.

Drug: JNJ-64140284; Drug: Placebo

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.

Drug: JNJ-64140284; Drug: Placebo

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.

Drug: JNJ-64140284; Drug: Placebo

Interventions

JNJ-64140284 DRUG

Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.

Part 1: Cohort 1 (Placebo or JNJ-64140284); Part 1: Cohort 2 (Placebo or JNJ-64140284); Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo); Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)

Placebo DRUG

Participant will receive matching placebo.

Part 1: Cohort 1 (Placebo or JNJ-64140284); Part 1: Cohort 2 (Placebo or JNJ-64140284); Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo); Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (1)

SGS Life Science Services

Antwerp, 2060, Belgium

Location

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 28, 2020
• Study Start: September 29, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)