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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060CLL1022 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 : ABAB | Experimental | Participants will receive 140 milligram (mg) of ibrutinib administered as one IMBRUVICA 140-mg oral capsule (Treatment A) in Period 1, 140 mg of ibrutinib administered as one ibrutinib 140-mg oral tablet (Treatment B) in Period 2, then Treatment A in period 3 and then followed by Treatment B in Period 4. Each intervention Period will be separated by a washout period of 7-9 days. |
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| Treatment Sequence 2 : BABA | Experimental | Participants will receive (Treatment B) Period 1, then Treatment A in Period 2, then Treatment B in Period 3 and then followed by Treatment A in Period 4. Each intervention Period will be separated by a washout period of 7-9 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib (test treatment) 140 milligram (mg), tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under Concentration from time zero to the last quantifiable (AUC [0-last]) | Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. | Predose up to Day 3 |
| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | 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. | Predose up to Day 3 |
| Maximum Observed Analyte Concentration (Cmax) | Maximum observed analyte concentration will be assessed. | Predose up to Day 3 |
| Time to Reach Maximum Concentration (Tmax) | Tmax is defined as actual sampling time to reach maximum observed analyte concentration will be assessed. | Predose up to Day 3 |
| Apparent Terminal Elimination Halflife (t1/2term) | The elimination halflife (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 calculated as 0.693/apparent terminal elimination rate constant (λz). | Predose up to Day 3 |
| Apparent Terminal Elimination Rate Constant (lambda z) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Approximately 59 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
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| IMBRUVICA | Drug | IMBRUVICA (reference treatment), 140-mg capsule |
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Apparent terminal elimination rate constant, estimated by linear regression using the terminal loglinear phase of the log transformed concentration versus time data. |
| Predose up to Day 3 |