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

NCT04033458 | Terminated Phase 1 DMC

• 3 other identifiers: CR1086482019-001975-3564140284EDI1004
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Peak Plasma Concentration (Cmax) of JNJ-64140284

  Cmax is defined as the peak plasma concentration of JNJ-64140284.

  Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose

• Area Under The Plasma Concentration-time Curve From 0 to t Hours Postdosing (AUC[0-t]) of JNJ-64140284

  AUC(0-t) is defined as the area under the plasma concentration-time curve from 0 to t hours postdosing of JNJ-64140284 (time t is the time of the last quantifiable concentration \[Clast\]).

  Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose

• Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of JNJ-64140284

  AUC(0-inf) is defined as the area under plasma concentration-time from time 0 to infinity extrapolated to infinity of JNJ-64140284.

  Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose

• Relative Bioavailability (F[rel]) of JNJ-64140284

  F(rel) is defined as the relative bio-availability of JNJ-64140284 calculated as individual Cmax and AUC treatment ratio's (for the comparison of the capsule \[solid 5 micro-meter (mcm) or solid 31 mcm\] to the solution and for the comparison of fed versus fasted for the capsule \[both for solid 5 mcm and solid 31 mcm\]).

  Predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36 and 48 hours postdose

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to 13 weeks

Study Arms (10)

Treatment Sequence ABECD

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence BCADE

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence CDBEA

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence DECAB

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence EADBC

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence DCEBA

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence EDACB

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence AEBDC

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence BACED

EXPERIMENTAL

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.

Drug: JNJ-64140284

Treatment Sequence CBDAE

EXPERIMENTAL

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.

Drug: JNJ-64140284

Interventions

JNJ-64140284 DRUG

Participants will receive JNJ-64140284 orally.

Also known as: AMPARγ8

Treatment Sequence ABECD; Treatment Sequence AEBDC; Treatment Sequence BACED; Treatment Sequence BCADE; Treatment Sequence CBDAE; Treatment Sequence CDBEA; Treatment Sequence DCEBA; Treatment Sequence DECAB; Treatment Sequence EADBC; Treatment Sequence EDACB

Eligibility Criteria

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

You may qualify if:

• Body Mass Index (BMI) between 18.0 and 29.9 kilograms per square meter (kg/m\^2) inclusive
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: July 29, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)