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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765CLL1001 | 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 compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants.
This is a randomized (individuals will be assigned by chance to study treatments), open-label (identity of assigned study drug will be known), 4-way crossover study to compare the effect of food and two fasting regimens on the pharmacokinetics of PCI-32765 in healthy adults. There will be approximately 52 (at least 25% women) participants (11 in each sequence in the 4-way crossover and 8 in an optional cohort). A screening phase will be followed by an open-label treatment phase consisting of 4 single-dose treatment periods of 420 mg PCI-32765 administered with or without food. Doses in successive open-label treatment periods will be separated by a washout period of 7 days. Participants will be confined to the study center from Day -1 of each treatment period (at least 10 hours before each study drug administration) until completion of the 72 hour pharmacokinetic blood sample collection on Day 4 of Period 4. Blood samples for pharmacokinetic analysis of PCI-32765 and metabolite PCI-45227 will be collected before dosing and over 72 hours after dosing in each treatment period. A follow-up visit approximately 10 days after the last dose will be made to measure lymphocyte count and to capture any additional adverse events. After completion of the 4-way crossover portion of the study, and in absence of significant safety observations at the 420 mg PCI-32765 dose, an additional separate cohort of 8 participants may be enrolled to participate in one treatment period and receive a dose of 840 mg in combination with a high-fat breakfast. Safety will be assessed throughout the study. The total study duration is a maximum of 85 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: PCI-32765 | Experimental | 420 mg capsules administered by mouth with 240 mL noncarbonated water 30 minutes after completing a high-fat breakfast |
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| Treatment B: PCI-32765 | Experimental | 420 mg capsules administered by mouth with 240 mL noncarbonated water after fasting for at least 10 hours and 30 minutes before starting a high-fat breakfast |
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| Treatment C: PCI-32765 | Experimental | 420 mg capsules administered by mouth with 240 mL noncarbonated water 2 hours after completing a high-fat breakfast |
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| Treatment D: PCI-32765 | Experimental | 420 mg capsules administered with 240 mL noncarbonated water after fasting at least 10 hours |
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| Treatment E: PCI-32765 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1: PCI-32765 | Drug | Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentrations of PCI-32765 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | |
| Area under the plasma concentration-time curve from time 0 to infinite time of PCI-32765 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | |
| Maximum plasma concentration of PCI-32765 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach the maximum plasma concentration of PCI-32765 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours | |
| Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation 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 |
|---|---|---|---|---|---|---|
| Neptune City | New Jersey | United States |
| 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. |
| Label | URL |
|---|---|
| Open-Label, Randomized, 4-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765 | View source |
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| Experimental |
840 mg capsules administered with 240mL noncarbonated water 30 minutes after completing a high-fat breakfast |
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| Sequence 2: PCI-32765 | Drug | Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C |
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| Sequence 3: PCI-32765 | Drug | Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D |
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| Sequence 4: PCI-32765 | Drug | Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A |
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| Sequence 5: PCI-32765 | Drug | After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK |
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| Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Elimination half-life of PCI-32765 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Relative bioavailability of PCI-32765 | Relative bioavailability is defined as the ratio of the area under the concentration curve to infinity between the test treatment and the reference treatment. | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Maximum plasma concentration of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Time to reach the maximum plasma concentration of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentrations of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Area under the plasma concentration-time curve from time 0 to infinite time of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Elimination half-life of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Relative bioavailability of metabolite PCI-45227 | Predose; postdose at 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours |
| Number of participants with adverse events | Up to 30 days following the last dose of study drug |
| Number of participants with adverse events of special interest (major hemorrhage and intracranial hemorrhage) | Up to 30 days following the last dose of study drug |