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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR1021 | Other Identifier | Janssen Pharmaceutical K.K. |
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The purpose of the study is to assess the safety and Pharmacokinetic (PK) profile of JNJ-56021927 and its active metabolite JNJ-56142060 after single-dose administration of 60 milligram (mg), 120 mg, and 240 mg JNJ-56021927 as the tablet formulation in healthy male Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive a single dose of 1 tablet of JNJ-56021927, 60 milligram (mg) on Day 1. |
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| Treatment B | Experimental | Participants will receive a single dose of JNJ-56021927, 120 mg (2 tablets*60 mg) on Day 1. |
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| Treatment C | Experimental | Participants will receive a single dose of JNJ-56021927, 240 mg (4 tablets*60 mg) on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-56021927 60 Milligram | Drug | JNJ-56021927 60 mg oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) will be assessed. | Predose, Up to Day 57 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed. | Predose, Up to Day 57 |
| Area Under Concentration from time zero to the last quantifiable AUC (0-last) | AUC from time zero to the last quantifiable concentration will be assessed. | Predose, Up to Day 57 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. AUC (0-infinity) will be assessed. | Predose, Up to Day 57 |
| Time to Last Quantifiable Plasma Concentration (Tlast) | The Tlast, time to last observed quantifiable plasma concentration will be assessed. | Predose, Up to Day 57 |
| Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC,ext) | Percentage of area under the plasma concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC,ext) is calculated as (AUC [0-infinity] minus AUC [0-last])/ AUC [0-infinity])*100. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kumamoto | Japan |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
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| JNJ-56021927 120 Milligram | Drug | JNJ-56021927 120 mg as 2 tablets of 60 mg. |
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| JNJ-56021927 240 Milligram | Drug | JNJ-56021927 240 mg as 4 tablets of 60 mg. |
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| Predose, Up to Day 57 |
| Apparent 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. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F will be calculated as CL/F = Dose/AUC [0-infinity] | Predose, Up to Day 57 |
| Apparent Terminal Elimination Half-life (t1/2term) | Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (λz) | Predose, Up to Day 57 |
| Apparent Terminal Elimination Rate Constant (lambda z) | Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data | Predose, Up to Day 57 |
| Apparent Volume of Distribution (Vd/F) | Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (λz)*AUC [0-infinity] | Predose, Up to Day 57 |
| Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax) | Metabolite to parent drug ratio for Cmax will be assessed. | Predose, Up to Day 57 |
| Metabolite to Parent Drug Ratio for Area Under Concentration from time zero to the last quantifiable concentration (MPR AUC [0-last]) | Metabolite to parent drug ratio for AUC [0-last] will be assessed. | Predose, Up to Day 57 |
| Metabolite to Parent Drug Ratio for Area Under Curve from time zero extrapolated to infinity (MPR AUC [0-infinity]) | Metabolite to parent drug ratio for AUC [0-infinity] will be assessed. | Predose, Up to Day 57 |
| Area Under Curve from time of administration to 24 hours post dosing | AUC from time of administration to 24 hours post dosing will be assessed. | Predose, Up to Day 57 |
| Area Under Curve from time of administration to 168 hours post dosing | AUC from time of administration to 168 hours post dosing will be assessed. | Predose, Up to Day 57 |