Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05201937 | A Study of JNJ-64281802 in Healthy Adult Participants | PHASE1 | COMPLETED | 33 | — | — | Feb 23, 2022 | Dec 11, 2022 | Mar 30, 2025 | 1 | Netherlands |
Cmax is defined as maximum observed plasma concentration of JNJ-64281802.
Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.
Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.
t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.
AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.
AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.
CL/F is defined as total apparent oral clearance of JNJ-64281802.
| Arm | Type | Description |
|---|---|---|
| Arm A: Panel 1 (JNJ-64281802 High Dose Regimen) | EXPERIMENTAL | Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24. |
| Arm A: Panel 2 (JNJ-64281802 High Dose Regimen) | EXPERIMENTAL | Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27. |
| Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen) | EXPERIMENTAL | Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24. |
| Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen) | EXPERIMENTAL | Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27. |
| Arm C: Panel 5 (JNJ-64281802 [Optional]) | EXPERIMENTAL | Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. |
| Arm C: Panel 6 (JNJ-64281802 [Optional]) | EXPERIMENTAL | Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. |
| Name | Type | Description |
|---|---|---|
| JNJ-64281802 | DRUG | JNJ-64281802 tablets will be administered orally as per the defined regimens. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant ...