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 300 milligram is a small molecule antiviral drug candidate being developed by Johnson & Johnson for the treatment of Influenza A Virus. It is an investigational therapy that has been studied in a Phase 1 clinical trial. The 300 milligram designation refers to a specific dose strength of the drug.
JNJ-63623872 300 milligram is being developed for the treatment of Influenza A Virus infection. It is an investigational antiviral candidate and has not been approved for any indication. The clinical program has focused on evaluating the drug in healthy volunteers to assess its pharmacokinetic properties.
JNJ-63623872 300 milligram is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. Johnson & Johnson is the sponsor of the clinical trial evaluating this drug candidate for Influenza A Virus.
JNJ-63623872 300 milligram is in Phase 1 clinical development. The Phase 1 trial for this drug candidate has been completed. It remains an investigational therapy and is not approved for commercial use.
JNJ-63623872 300 milligram has been evaluated in one completed Phase 1 clinical trial, NCT02659735. The study assessed the relative oral bioavailability of JNJ-63623872 administered as oral concept formulations compared to the current tablet formulation. It enrolled 90 healthy volunteers in Belgium and was a randomized, controlled trial.