An Open-Label Phase 1 Study to Determine the Pharmacokinetics, Metabolism, and Routes of Excretion of (14C) Radiolabeled PCI-32765 in Healthy Male Subjects
This is an open-label (all people know the identity of the intervention), single-center,
single-dose study in healthy male participants. Six men will be enrolled to allow a minimum
of 4 participants to complete the study. All participants will receive a single oral
solution dose of 50 to 140 mg ibrutinib containing 1480 kBq (40 µCi) of 14C labeled
ibrutinib, constituting a total radiation burden of approximately 0.916 mSv (ICRP risk
category IIa). The duration of the study is approximately 73 days including screening period
of 28 days, treatment period of 15 days, and follow-up period of 30 days. Safety will
include adverse events, laboratory safety, 12 lead electrocardiogram, physical examination,
and vital signs.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum concentration (Cmax) of ibrutinib
Pharmacokinetic parameter Cmax of ibrutinib will be determined.
Day 1 (Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours)
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Belgium: Federal Agency for Medicines and Health Products, FAMHP
CR100885
NCT01674322
August 2012
September 2012
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