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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765CLL1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.
This is a single-center, open-label (all people know the identity of the intervention), sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast, ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water. The participants will leave the study center on Day 10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibrutinib and Ketoconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ibrutinib plasma concentrations after administration on Day 1 | over 72 hours after dosing on Day 1 | |
| Ibrutinib plasma concentrations after administration on Day 7 | over 72 hours after dosing on Day 7 | |
| Metabolite PCI-45227 plasma concentrations after administration on Day 1 | over 72 hours after dosing on Day 1 | |
| Metabolite PCI-45227 plasma concentrations after administration on Day 7 | over 72 hours after dosing on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Ibrutinib urine concentrations after administration on Day 1 | over 72 hours after dosing on Day 1 | |
| Ibrutinib urine concentrations after administration on Day 7 | over 72 hours after dosing on Day 7 |
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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 |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketoconazole | Drug | Ketoconazole (400 mg [2 x 200 mg] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9. |
|
| Metabolite PCI-45227 urine concentrations after administration on Day 1 | over 72 hours after dosing on Day 1 |
| Metabolite PCI-45227 urine concentrations after administration on Day 7 | over 72 hours after dosing on Day 7 |
| Incidence of adverse events as a measure of safety and tolerability | Approximately 41 days |