Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-56021927 60 Milligram · 1 trial · 1 indication
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...
JNJ-56021927 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed pharmacokinetic study in healthy male Japanese participants. The drug is being developed by Johnson & Johnson.
JNJ-56021927 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule currently in Phase 1 clinical development.
JNJ-56021927 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 1 study has been completed, and the drug remains under clinical investigation.
JNJ-56021927 has one completed clinical trial, NCT02835508, titled "Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese Participants." This Phase 1 study enrolled 18 healthy male participants aged 20 years and older in Japan.
Yes, JNJ-56021927 60 Milligram refers to the same drug, JNJ-56021927, at a specific dosage strength. The drug is an investigational small molecule being developed by Johnson & Johnson for study in healthy volunteers.