A Study of JNJ-64140284 Solid Dose Formulations in Healthy Male Participants

NCT ID: NCT04033458

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2019-08-01

Brief Summary

The purpose of this study is to compare the pharmacokinetic profile of a single dose of two solid dosage formulations relative to a reference formulation (solution in polyethylene glycol-400 [PEG-400]) of JNJ-64140284 in healthy male participants under fasting condition and to assess the effect of food on the bioavailability of two solid dosage formulations of JNJ-64140284.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Sequence ABECD

Participants will receive single oral dose of JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 2 in fasted condition (Treatment B), then JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) and, then JNJ-64140284 Regimen 4 in fed condition (Treatment D) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence BCADE

Participants will receive single oral dose of JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) then JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) and, then JNJ-64140284 Regimen 5 in fed condition (Treatment E) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence CDBEA

Participants will receive single oral dose of JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) then, JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) and then, JNJ-64140284 Regimen 1 in fasted condition (Treatment A) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence DECAB

Participants will receive single oral dose of JNJ-64140284 Regimen 4 in fed condition (Treatment D) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) then JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regiment 1 in fasted condition (Treatment A) and then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence EADBC

Participants will receive single oral dose of JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 1 in fasted condition (Treatment A) then JNJ-64140284 Regimen 4 in fed condition (Treatment D) then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) and then, JNJ-64140284 Regimen 3 in fed condition (Treatment C) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence DCEBA

Participants will receive single oral dose of JNJ-64140284 Regimen 4 in fed condition (Treatment D) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) then JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 2 in fasted condition (Treatment B) and then JNJ-64140284 Regimen 1 in fasted condition (Treatment A) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence EDACB

Participants will receive single oral dose of JNJ-64140284 Regimen 5 in fed condition (Treatment E) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) then JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 3 in fed condition (Treatment C) and then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence AEBDC

Participants will receive single oral dose of JNJ-64140284 Regimen 1 in fasted condition (Treatment A) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) then JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 4 in fed condition (Treatment D) and then JNJ-64140284 Regimen 3 in fed condition (Treatment C) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence BACED

Participants will receive single oral dose of JNJ-64140284 Regimen 2 in fasted condition (Treatment B) followed by JNJ-64140284 Regimen 1 in fasted condition (Treatment A) then JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regimen 5 in fed condition (Treatment E) and then JNJ-64140284 Regimen 4 in fed condition (Treatment D) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Treatment Sequence CBDAE

Participants will receive single oral dose of JNJ-64140284 Regimen 3 in fed condition (Treatment C) followed by JNJ-64140284 Regimen 2 in fasted condition (Treatment B) then JNJ-64140284 Regimen 4 in fed condition (Treatment D) followed by JNJ-64140284 Regimen 1 in fasted condition (Treatment A) and then JNJ-64140284 Regimen 5 in fed condition (Treatment E) in Treatment Periods 1 to 5 respectively. All treatment periods will be separated by a wash out period of at least 5 days and maximally 12 days.

Group Type: EXPERIMENTAL

JNJ-64140284

Intervention Type: DRUG

Participants will receive JNJ-64140284 orally.

Interventions

JNJ-64140284

Participants will receive JNJ-64140284 orally.

Intervention Type: DRUG

Other Intervention Names

AMPARγ8

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) between 18.0 and 29.9 kilograms per square meter (kg/m^2) inclusive
• Participants must be healthy on the basis of clinical laboratory tests performed at screening. 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 once during the screening phase. 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 according to the investigator. 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 examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) (means of triplicate ECG, inclusive QTcF less than or equal to [<=] 450 milliseconds [msec]) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of left bundle branch block (LBBB), atrioventricular (AV) block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
• Non-smokers (not smoked cigarettes or equivalent or not used nicotine-based products for 3 months prior to screening)
• Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control for example, either condom or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for the duration of the study plus 3 months after receiving the last dose of study drug, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an additional method of birth control (which may include a hormonal method, an intrauterine device [IUD] or an intrauterine system [IUS]) for at least the same duration. Men with a partner who is pregnant, you must use a condom to avoid exposure to the unborn child

Exclusion Criteria

• 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
• Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
• Participant has a history of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before Screening or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission
• Drinks, on average, more than 5 cups of tea or coffee or 8 cans of cola per day
• Clinically significant acute illness within 7 days prior to study drug administration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2019-001975-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64140284EDI1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR108648

Identifier Type: -

Identifier Source: org_study_id