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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02117505 | A Crossover Study to Evaluate Relative Bioavailability of Two JNJ-54781532 Tablet Formulations in Healthy Adult Participants | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2014 | Jun 1, 2014 | Jun 26, 2014 | 1 | Belgium |
The Cmax is the maximum observed plasma concentration.
The tmax is time to reach the maximum observed plasma 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.
| Arm | Type | Description |
|---|---|---|
| Group 1 (Formulation 2 Then Formulation 1) | EXPERIMENTAL | Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in first treatment period; followed by JNJ-54781532 formulation 1 as 150 mg orally (5\*30 mg tablet=150 mg) in second treatment period. A washout period of at least 7 days will be maintained between each treatment period. |
| Group 2 (Formulation 1 Then Formulation 2) | EXPERIMENTAL | Single-dose of JNJ-54781532 formulation 1 will be administered as 150 mg oral tablet (5\*30 mg tablet=150 mg) in first treatment period; followed by JNJ-54781532 formulation 2 as 150 mg oral tablet in second treatment period. A washout period of at least 7 days will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Formulation 2 | DRUG | Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods. |
| Formulation 1 | DRUG | Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5\*30 mg tablet=150 mg) in one of the treatment periods. |
Inclusion Criteria: * Female participants must be either: 1) not of childbearing potential: postmenopausal or surgically sterile at screening 2) of child-bearing potential: Must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting ...