A Pharmacokinetic Study in Healthy Participants to Assess the Pharmacokinetics and Safety of a Supratherapeutic Dose of PCI-32765 (Ibrutinib) Capsule and Solution Formulations Administered With Food

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.

Inclusion Criteria:

- Women must be postmenopausal or surgically sterile

- A sexually active man with a woman of child-bearing potential that has not had a
vasectomy must agree to use an adequate contraception method during the study and for
3 months after receiving the last dose of study drug, and to not donate sperm during
the study and for 3 months after receiving the last dose of study drug

- Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg

- Blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, and no
higher than 90 mmHg diastolic

- 12-lead ECG consistent with normal cardiac conduction and function

- Non-smoker

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders, lipid abnormalities, significant pulmonary disease, including
bronchospastic respiratory disease, diabetes mellitus, renal or hepatic
insufficiency, thyroid disease, neurologic or psychiatric disease, infection, history
of immune disorders, or any other illness the investigator considers should exclude
the participant or could interfere with the interpretation of the study results

- Clinically significant abnormal values for hematology, coagulation, PFA 100, clinical
chemistry, or urinalysis at screening or at admission to the study center as deemed
appropriate by the investigator

- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen, and hormonal replacement therapy within 14
days before the first dose of the study drug is scheduled

- Use of herbal supplements such as St. John's Wort within 30 days of the first study
drug administration

- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of
Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before screening or
positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1 of
each treatment period

- History of clinically significant allergies, especially known hypersensitivity or
intolerance to sulfonamide or beta-lactam antibiotics

- Known allergy to the study drug or any of the excipients of the formulation

- Donated blood or blood products or had substantial loss of blood (more than 500 mL)
within 3 months before the first administration of study drug or intention to donate
blood or blood products during the study

- Received an experimental drug or used an experimental medical device within 1 month
or within a period less than 10 times the drug's half-life, whichever is longer,
before the first dose of the study drug is scheduled

- Unable to swallow solid, oral dosage forms whole with the aid of water

- A woman that is pregnant, breast-feeding or planning to become pregnant during the
study

- A man who plans to father a child while enrolled in the study or within 3 months
after the last dose of study drug

- Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B
surface antigen, or hepatitis C antibodies

- History of smoking or use of nicotine-containing substances within the previous 2
months, or positive cotinine test at screening

- Preplanned surgery or procedures that would interfere with the conduct of the study