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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765CLL1011 | Other Identifier | Janssen Research & Development, LLC | |
| 2013-000963-96 | EudraCT Number |
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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The purpose of this study is to assess the absolute bioavailability of oral PCI-32765 and the effect of grapefruit juice on the absorption of PCI-32765 in healthy adult participants.
This is an open-label (identity of assigned study drug will be known), sequential and 2-way crossover design, pharmacokinetic (study of what the body does to a drug) study to assess the absolute bioavailability of oral (by mouth) PCI-32765 and the effect of grapefruit juice on the absorption of PCI-32765 in approximately 8 healthy adult participants. The duration of the study is approximately 45 days (screening, treatment, and follow-up). All patients will receive PCI-32765 560 mg (Treatment A) administered by mouth in the first period and Treatment B (560 mg administered by mouth without grapefruit juice) and Treatment C (140 mg administered by mouth with grapefruit juice) according to a randomization schedule in Periods 2 and 3. Participants will fast overnight for at least 10 hours prior to study drug dosing. Participants will stay in the study center for pharmacokinetic sampling. Serial pharmacokinetic samples will be collected before dosing and over 72 hours after dosing and safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI-32765 | Experimental | During Period 1, all patients will receive PCI-32765 560 mg administered by mouth (Treatment A). In Periods 2 and 3, patients will receive PCI-32765 560 mg administered by mouth without grapefruit juice (Treatment B) and PCI-32765 140 mg administered by mouth with grapefruit juice (Treatment C) according to a randomization schedule. An intravenous dose of 13C6 PCI-32765 will be administered 2 hours after each oral dose for reference purposes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI-32765 (Treatment A) | Drug | 560 mg capsules administered by mouth on Day 1, Period 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to 24 hours of PCI-32765 | Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h | |
| Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of PCI-32765 | Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h | |
| Area under the plasma concentration-time curve from time 0 to infinite time of PCI-32765 | Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h | |
| Absolute bioavailability of PCI-32765 | Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of PCI-32765 | Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h | |
| Time to reach the maximum plasma concentration of PCI-32765 |
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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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25724156 | Derived | de Jong J, Sukbuntherng J, Skee D, Murphy J, O'Brien S, Byrd JC, James D, Hellemans P, Loury DJ, Jiao J, Chauhan V, Mannaert E. The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic leukemia. Cancer Chemother Pharmacol. 2015 May;75(5):907-16. doi: 10.1007/s00280-015-2708-9. Epub 2015 Feb 28. |
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| PCI-32765 (Treatment B) |
| Drug |
560 mg capsules administered by mouth (without grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule |
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| PCI-32765 (Treatment C) | Drug | 140 mg capsule administered by mouth (with grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule |
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| 13C6 PCI-32765 (reference) | Drug | 100 mcg administered intravenously 2 h after study drug |
|
| Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h |
| Elimination half-life of PCI-32765 | Predose, and postdose at 30 min, 1 h, 1.5 h, 2 h, 2 h 2 min, 2 h 5 min, 2.2 h, 2.25 h, 2.5 h, 3 h, 3.5 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h, 72 h |
| Number of participants affected by an adverse event | Up to 30 days after the last dose of study medication |
| ID | Term |
|---|---|
| C551803 | ibrutinib |
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