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| ID | Type | Description | Link |
|---|---|---|---|
| 64530440HEP1001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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Stopped due to a strategic decision.
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| JNJ-0440 (High Dose) or Placebo | Experimental | Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-0440 | Drug | JNJ-0440 tablets will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida Hospital | Tokyo | 130-0004 | Japan |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Drug | Matching placebo tablets will be administered orally. |
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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 |