Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:June 2016
End Date:August 2016

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A Single-Dose, Open-Label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of an Ibrutinib 560-mg Tablet Compared to the Four IMBRUVICA 140 mg Capsules

The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of
ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.


Inclusion Criteria:

- Signed an informed consent form (ICF) indicating that he or she understands the
purpose of and procedures required for the study and is willing to participate in the
study, before any study related procedures take place

- Willing and able to adhere to the prohibitions and restrictions specified in the
protocol

- If a woman, must be of non-childbearing potential, defined as either: a)
Postmenopausal: A postmenopausal state is defined as no menses for at least 12 months
without an alternative medical cause and a serum follicle stimulating hormone (FSH)
level in the postmenopausal range (greater than [>]40 international units per liter
[IU/L] or milliinternational units per milliliter [mIU/mL]). b) Permanently sterile:
Permanent sterilization methods include hysterectomy, bilateral salpingectomy,
bilateral tubal occlusion/ligation procedures (without reversal operation), bilateral
oophorectomy, and/or transcervical sterilization

- If a woman, must have a negative serum beta-human chorionic gonadotropin (beta-hCG)
pregnancy test at screening and on Day -1 of each treatment period

- Non-smoker for at least 2 months prior to screening

Exclusion Criteria:

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

- 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

- Unable to swallow solid, oral dosage forms whole with the aid of water (participants
may not chew, divide, dissolve, or crush the study drug)

- Positive test for human immunodeficiency virus type 1 (HIV-1) or HIV-2 antibodies at
screening
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