The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.
This is an open-label (identity of assigned study drug will be known), 2-period, sequential, exploratory study in healthy adult men and women to determine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) as a capsule or solution formulation administered with food. Eight participants (including at least 2 women) will be enrolled and receive 2 treatments: PCI-32765 840 mg will be administered as capsule (Treatment A in Period 1) and solution (Treatment B in Period 2) formulations. All participants will receive both treatments with a 7-day washout period between doses. A high-fat breakfast will be provided 2 hours before dosing. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected before dosing and over 72 hours after each dose and safety will be monitored throughout the study. The total duration of the study will be approximately 46 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
840 mg capsule formulation administered by mouth on Day 1
840 mg solution formulation administered by mouth on Day 1
Unnamed facility
Neptune City, New Jersey, United States
Maximum observed plasma concentrations of ibrutinib and metabolite PCI-45227
Time frame: Up to postdose at 72 h
Area under the plasma concentration-time curve of ibrutinib and metabolite PCI-45227
Time frame: Up to postdose at 72 h
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Time frame: Up to 30 days after the last dose of study medication
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