A Study of JNJ-64140284 in Healthy Male Participants

NCT ID: NCT04566926

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2021-04-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Cohort 1 (Placebo or 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.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participant will receive matching placebo.

Part 1: Cohort 2 (Placebo or 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.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participant will receive matching placebo.

Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo)

Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participant will receive matching placebo.

Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)

Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participant will receive matching placebo.

Interventions

JNJ-64140284

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

Intervention Type: DRUG

Placebo

Participant will receive matching placebo.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

SGS Life Science Services

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2020-002616-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64140284EDI1005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108866

Identifier Type: -

Identifier Source: org_study_id