| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02835508 | Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese Participants | PHASE1 | COMPLETED | 18 | — | — | Jun 1, 2016 | Dec 1, 2016 | Jan 11, 2017 | 1 | Japan |
Maximum observed plasma concentration (Cmax) will be assessed.
Actual sampling time to reach maximum observed analyte concentration (Tmax) will be assessed.
AUC from time zero to the last quantifiable concentration will be assessed.
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.
The Tlast, time to last observed quantifiable plasma concentration will be assessed.
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.
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 \[0-infinity\]
Apparent terminal elimination half-life, calculated as 0.693/apparent terminal elimination rate constant (λz)
Apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data
Apparent volume of distribution based on the terminal phase following oral administration calculated as Vd/F = Dose/ apparent terminal elimination rate constant (λz)\*AUC \[0-infinity\]
Metabolite to parent drug ratio for Cmax will be assessed.
Metabolite to parent drug ratio for AUC \[0-last\] will be assessed.
Metabolite to parent drug ratio for AUC \[0-infinity\] will be assessed.
AUC from time of administration to 24 hours post dosing will be assessed.
AUC from time of administration to 168 hours post dosing will be assessed.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Participants will receive a single dose of 1 tablet of JNJ-56021927, 60 milligram (mg) on Day 1. |
| Treatment B | EXPERIMENTAL | Participants will receive a single dose of JNJ-56021927, 120 mg (2 tablets\*60 mg) on Day 1. |
| Treatment C | EXPERIMENTAL | Participants will receive a single dose of JNJ-56021927, 240 mg (4 tablets\*60 mg) on Day 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-56021927 60 Milligram | DRUG | JNJ-56021927 60 mg oral tablet. |
| JNJ-56021927 120 Milligram | DRUG | JNJ-56021927 120 mg as 2 tablets of 60 mg. |
| JNJ-56021927 240 Milligram | DRUG | JNJ-56021927 240 mg as 4 tablets of 60 mg. |
Inclusion Criteria: * Participant must have a body mass index between 18.0 and 29.9 Kilogram per meter square (kg/m\^2), inclusive, and a body weight not less than 50 Kilogram (kg) * Participant must have a blood pressure between 90 and 140 Millimeters of Mercury (mm Hg) systolic, inclusive, and no...