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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060CLL1021 | 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 | Experimental | Participants will receive treatment A, on Day 1 of Intervention Period 1 followed by treatment B , on Day 1 of Intervention Period 2 followed by treatment A, Day 1 of Intervention Period 3 and then followed by treatment B, on Day 1 of Intervention Period 4. Each intervention Period will be separated by a washout period of 7-9 days. |
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| Treatment Sequence 2 | Experimental | Participants will receive treatment B, on Day 1 of Intervention Period 1 followed by treatment A, on Day 1 of Intervention Period 2 followed by treatment B, Day 1 of Intervention Period 3 and then followed by treatment A, on Day 1 of Intervention 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 |
|---|---|---|---|---|
| IMBRUVICA (Treatment A) | Drug | IMBRUVICA (reference treatment), 4*140 milligram (mg), capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Ibrutinib | The Cmax is the maximum observed plasma concentration. | Day 1 (Pre-dose) up to Day 3 |
| Time to reach maximum concentration (tmax) of Ibrutinib | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Day 1 (Pre-dose) up to Day 3 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of Ibrutinib | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Day 1 (Pre-dose) up to Day 3 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Ibrutinib | 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. | Day 1 (Pre-dose) up to Day 3 |
| Elimination Rate Constant (Lambda[z]) of Ibrutinib | 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. | Day 1 (Pre-dose) up to Day 3 |
| Terminal Half-Life (t[1/2]) of Ibrutinib | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events as a measure of safety and tolerability | Baseline up to 14 days after last dose of study drug (Day 17) |
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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 |
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| C551803 | ibrutinib |
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| Ibrutinib (Treatment B) | Drug | Ibrutinib (test treatment), 1*560 mg, tablet. |
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| Day 1 (Pre-dose) up to Day 3 |
| Maximum Plasma Concentration (Cmax) of IMBRUVICA | The Cmax is the maximum observed plasma concentration. | Day 1 (Pre-dose) up to Day 3 |
| Time to reach maximum concentration (tmax) of IMBRUVICA | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Day 1 (Pre-dose) up to Day 3 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of IMBRUVICA | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Day 1 (Pre-dose) up to Day 3 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of IMBRUVICA | 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. | Day 1 (Pre-dose) up to Day 3 |
| Elimination Rate Constant (Lambda[z]) of IMBRUVICA | 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. | Day 1 (Pre-dose) up to Day 3 |
| Terminal Half-Life (t[1/2]) of IMBRUVICA | 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). | Day 1 (Pre-dose) up to Day 3 |