A Phase 1 interventional study of Ibrutinib and Ketoconazole in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-19.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.
Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.
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Exclusion Criteria:
Drug: Ibrutinib · Drug: Ketoconazole
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.
Ketoconazole (400 mg \[2 x 200 mg\] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.
Ibrutinib plasma concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Ibrutinib plasma concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Metabolite PCI-45227 plasma concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Metabolite PCI-45227 plasma concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Ibrutinib urine concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Ibrutinib urine concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Metabolite PCI-45227 urine concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Metabolite PCI-45227 urine concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Incidence of adverse events as a measure of safety and tolerability
Time frame: Approximately 41 days
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ibrutinib · Ketoconazole
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