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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR1007 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability (the extent to which a medication or other substance becomes available to the body) of JNJ-56021927 when administered as 7 test tablet formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927 in healthy male participants under fasted conditions at a single dose of 240 mg.
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), single-center, 8-treatment, parallel-group (each group of participants will be treated at the same time) study. Approximately 120 participants (15 participants in each treatment group) will participate in this study. All participants will be randomly assigned to 1 of 8 possible treatments (A, B, C, D, E, F, G, and H). The study will consist of a screening phase (within 21 days before the first administration of the study medication), a treatment phase with 8 parallel single-dose treatments (8 days); a follow up phase (42 days) and an end-of-study or early withdrawal assessments (Day 57). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored throughout the study. The duration of participation in the study for an individual participant will be approximately 78 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | 15 participants will receive 240-mg dose as Softgel Capsule Formulation of JNJ-56021927. |
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| Treatment B | Experimental | 15 participants will receive 240-mg dose as Tablet Formulation number 1 of JNJ-56021927. |
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| Treatment C | Experimental | 15 participants will receive 240-mg dose as Tablet Formulation number 2 of JNJ-56021927. |
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| Treatment D | Experimental | 15 participants will receive 240-mg dose as Tablet Formulation number 3 of JNJ-56021927. |
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| Treatment E | Experimental | 15 participants will receive 240-mg dose as Tablet Formulation number 4 of JNJ-56021927. |
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| Treatment F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-56021927 capsule | Drug | Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-56021927 | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-56021927 | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Area Under the Plasma Concentration-Time Curve From Time of Administration to 72 hours After Dosing (AUC 0-72h) of JNJ-56021927 | The AUC 0-72h is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Area Under the Plasma Concentration-Time Curve From Time of Administration to 168 hours After Dosing (AUC 0-168h) of JNJ-56021927 | The AUC 0-168h is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of JNJ-56021927 | The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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15 participants will receive 240-mg dose as Tablet Formulation number 5 of JNJ-56021927.
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| Treatment G | Experimental | 15 participants will receive 240-mg dose as Tablet Formulation number 6 of JNJ-56021927. |
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| Treatment H | Experimental | 15 participants will receive 240-mg dose as Tablet Formulation number 7 of JNJ-56021927. |
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| JNJ-56021927 tablet | Drug | Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1. |
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| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-56021927 | The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration and lambda[z] is the terminal rate-constant of the semi logarithmic drug concentration-time curve. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Elimination Half-Life Period (T1/2) of JNJ-56021927 | The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half of its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| First-order Rate Constant of JNJ-56021927 | The first-order 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. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Time to Last Quantifiable Plasma Concentration (tlast) of JNJ-56021927 | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Relative Bioavailability (Frel) of JNJ-56021927 | Relative bioavailability is the percentage of the administered dose that is systemically available. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Metabolite to Parent Drug Ratio for Cmax of JNJ-56021927 | Metabolite to parent drug ratio for maximum observed plasma concentration. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Metabolite to Parent Drug Ratio for AUClast of JNJ-56021927 | Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration (Clast). | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Metabolite to Parent Drug Ratio for AUCinfinity of JNJ-56021927 | Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/ first-order rate constant, in which Clast is the last observed quantifiable concentration. | Pre-dose, and post-dose Day 1 (0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours), Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 36, 43, 50, 57 |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerabilty | Up to Day 57 |
| ID | Term |
|---|---|
| C572045 | apalutamide |
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