A Study of JNJ-64530440 in Healthy Japanese Male Participants

NCT03915886 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CR10860364530440HEP1001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64530440 (JNJ-0440) in healthy Japanese adult male participants after single oral dose administration with ascending dose design.

Conditions

Healthy

Outcome Measures

Primary Outcomes (16)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical agent under study.

  Approximately up to 37 days

• Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-0440

  Cmax is defined as the maximum observed plasma analyte concentration.

  Up to follow-up visit (approximately up to Day 9)

• Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-0440

  Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.

  Up to follow-up visit (approximately up to Day 9)

• Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0- 24h]) of JNJ-0440

  AUC(0-24h) is area under the plasma concentration-time curve from time zero to 24 hours, calculated by linear-linear trapezoidal summation.

  Up to follow-up visit (approximately up to Day 9)

• Area Under the Plasma Concentration-time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-0440

  AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.

  Up to follow-up visit (approximately up to Day 9)

• Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-0440

  AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.

  Up to follow-up visit (approximately up to Day 9)

• Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-0440

  Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  Up to follow-up visit (approximately up to Day 9)

• Apparent Terminal Elimination Half-Life (t1/2) of JNJ-0440

  The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic analyte concentration time curve, and is calculated as 0.693/lambda(z).

  Up to follow-up visit (approximately up to Day 9)

• Apparent Volume of Distribution (Vdz/F)

  The Vdz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution based on the terminal phase after extravascular administration, uncorrected for absolute bioavailability and calculated as dose/(lambda (z)\*AUC\[0-infinity\]).

  Up to follow-up visit (approximately up to Day 9)

• Apparent Total Clearance (CL/F)

  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as dose/AUC(0-infinity).

  Up to follow-up visit (approximately up to Day 9)

• Amount of JNJ-0440 Excreted in Urine within the Time Interval x to y (Ae[x-y])

  Ae(x-y) is the amount of JNJ-0440 excreted into urine for the collection interval from x to y hours, where x and y are the start and end times of the interval, respectively, calculated by multiplying the urinary volume with the urinary concentration for that interval.

  Up to 72 hours postdose

• Cumulative Urinary Recovery (Ae[0-x])

  Ae(0-x) is the sum of Ae values for all collection intervals up to 72 hours postdose.

  Up to 72 hours postdose

• Total Cumulative Urinary Recovery (Ae[total])

  Ae(total) is the sum of Ae values for all collection intervals.

  Up to 72 hours postdose

• Percentage of JNJ-0440 Excreted in Urine (Ae%dose[0-x])

  The Ae%dose(0-x) is the percentage of cumulative JNJ-0440 dose recovered into the urine for all collection intervals up to x hours postdose, calculated as (Ae/dose\[0-x\])∗100.

  Up to 72 hours postdose

• Percentage of JNJ-0440 Excreted in Urine (Ae%dose[total])

  Ae%dose(total) is the percentage of total JNJ-0440 dose recovered into the urine for all collection intervals, calculated as (Ae/dose\[total\])∗100.

  Up to 72 hours postdose

• Renal Clearance (CLr) of JNJ-0440

  The CLr is the renal clearance of the drug, calculated as Ae(total)/AUC(0-infinity).

  Up to 72 hours postdose

Study Arms (3)

JNJ-0440 (Low Dose) or Placebo

EXPERIMENTAL

Participants will receive single oral dose (low) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion.

Drug: JNJ-0440; Drug: Placebo

JNJ-0440 (Medium Dose) or Placebo

EXPERIMENTAL

Participants will receive single oral dose (medium) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion.

Drug: JNJ-0440; Drug: Placebo

JNJ-0440 (High Dose) or Placebo

EXPERIMENTAL

Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions.

Drug: JNJ-0440; Drug: Placebo

Interventions

JNJ-0440 DRUG

JNJ-0440 tablets will be administered orally.

JNJ-0440 (High Dose) or Placebo; JNJ-0440 (Low Dose) or Placebo; JNJ-0440 (Medium Dose) or Placebo

Placebo DRUG

Matching placebo tablets will be administered orally.

JNJ-0440 (High Dose) or Placebo; JNJ-0440 (Low Dose) or Placebo; JNJ-0440 (Medium Dose) or Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI; weight \[kg\]/height\^2 \[m\]\^2) between 18.0 and 30.0 kilogram per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kilogram (kg), at time of screening
• Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities 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
• Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site. If the results of the biochemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if these are grade 1 abnormal values and 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
• Blood pressure (after the participants has been supine for 5 minutes) between 90 and 140 millimeter of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
• Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the study drug

You may not qualify if:

• Any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
• Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
• History of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
• Known allergy to heparin or history of heparin induced thrombocytopenia
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening or at admission to the study site

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Sumida Hospital

Tokyo, 130-0004, Japan

Location

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: April 15, 2019
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)