Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-63623872 300 milligram · 1 trial · 1 indication
The Cmax is the maximum observed plasma concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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(last) and C(last)/lambda(z); wherein AUC(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.
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.
The elimination half-life (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 drug concentration-time curve, and is calculated as 0.693/lambda(z).
| Arm | Type | Description |
|---|---|---|
| Panel 1: Treatment ADBC | EXPERIMENTAL | Participants will receive Treatment A (600 milligram \[mg\] JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 1; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 2; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 3; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period. |
| Panel 1: Treatment BACD | EXPERIMENTAL | Participants will receive Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 1; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 2; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 3; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period. |
| Panel I: Treatment CBDA | EXPERIMENTAL | Participants will receive Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 1; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 2; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 3; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period. |
| Panel I: Treatment DCAB | EXPERIMENTAL | Participants will receive Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 1; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 2; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 3; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period. |
| Panel 2: Treatment EFG | EXPERIMENTAL | Participants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period. |
| Panel 2: Treatment FGE | EXPERIMENTAL | Participants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period. |
| Panel 2: Treatment GEF | EXPERIMENTAL | Participants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period. |
| Panel 2: Treatment GFE | EXPERIMENTAL | Participants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period. |
| Panel 2: Treatment FEG | EXPERIMENTAL | Participants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period. |
| Panel 2: Treatment EGF | EXPERIMENTAL | Participants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| JNJ-63623872 300 milligram (mg) | DRUG | Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1. |
| JNJ-63623872 600 mg | DRUG | Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1. |
Inclusion Criteria: * A female participants must be either: a) Not of childbearing potential: postmenopausal greater than (\>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 internation...
JNJ-63623872 is an investigational small molecule being developed for the treatment of Influenza A Virus infection. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.
JNJ-63623872 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for the treatment of Influenza A Virus infection.
JNJ-63623872 is in Phase 1 clinical development. It is an investigational drug for the treatment of Influenza A Virus infection and has not yet been approved by regulatory authorities. The drug is still in the early stages of clinical testing to evaluate its safety and pharmacokinetics in humans.
JNJ-63623872 has one completed Phase 1 clinical trial, identified as NCT02659735. This study assessed the relative oral bioavailability of JNJ-63623872 administered as oral concept formulations compared to the current tablet formulation. The trial enrolled 90 participants in Belgium and included healthy volunteers.
JNJ-63623872 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Influenza A Virus infection. The drug is still being studied in clinical trials and has not yet received regulatory approval for any indication.