Clinical trial NCT02841150: Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Ibrutinib
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Time to reach maximum concentration (tmax) of Ibrutinib
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of Ibrutinib
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Ibrutinib
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Elimination Rate Constant (Lambda[z]) of Ibrutinib
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Terminal Half-Life (t[1/2]) of Ibrutinib
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Maximum Plasma Concentration (Cmax) of IMBRUVICA
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Time to reach maximum concentration (tmax) of IMBRUVICA
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of IMBRUVICA
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of IMBRUVICA
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Elimination Rate Constant (Lambda[z]) of IMBRUVICA
timeFrame: Day 1 (Pre-dose) up to Day 3
measure: Terminal Half-Life (t[1/2]) of IMBRUVICA
timeFrame: Day 1 (Pre-dose) up to Day 3
Secondary outcomes:
measure: Number of participants with adverse events and serious adverse events as a measure of safety and tolerability
timeFrame: Baseline up to 14 days after last dose of study drug (Day 17)
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: