Tempe, Arizona, United States
NCT Number: NCT02841150
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA 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.
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Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
IMBRUVICA (Treatment A)
DrugIMBRUVICA (reference treatment), 4*140 milligram (mg), capsules.
Other names: Ibrutinib
Ibrutinib (Treatment B)
DrugIbrutinib (test treatment), 1*560 mg, tablet.
Primary outcomes
-
Maximum Plasma Concentration (Cmax) of Ibrutinib
Time frame: Day 1 (Pre-dose) up to Day 3
The Cmax is the maximum observed plasma concentration.
-
Time to reach maximum concentration (tmax) of Ibrutinib
Time frame: Day 1 (Pre-dose) up to Day 3
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
-
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of Ibrutinib
Time frame: Day 1 (Pre-dose) up to Day 3
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
-
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Ibrutinib
Time frame: Day 1 (Pre-dose) up to Day 3
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
-
Elimination Rate Constant (Lambda[z]) of Ibrutinib
Time frame: Day 1 (Pre-dose) up to Day 3
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
-
Terminal Half-Life (t[1/2]) of Ibrutinib
Time frame: Day 1 (Pre-dose) up to Day 3
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
-
Maximum Plasma Concentration (Cmax) of IMBRUVICA
Time frame: Day 1 (Pre-dose) up to Day 3
The Cmax is the maximum observed plasma concentration.
-
Time to reach maximum concentration (tmax) of IMBRUVICA
Time frame: Day 1 (Pre-dose) up to Day 3
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
-
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of IMBRUVICA
Time frame: Day 1 (Pre-dose) up to Day 3
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
-
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of IMBRUVICA
Time frame: Day 1 (Pre-dose) up to Day 3
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
-
Elimination Rate Constant (Lambda[z]) of IMBRUVICA
Time frame: Day 1 (Pre-dose) up to Day 3
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
-
Terminal Half-Life (t[1/2]) of IMBRUVICA
Time frame: Day 1 (Pre-dose) up to Day 3
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Secondary outcomes
-
Number of participants with adverse events and serious adverse events as a measure of safety and tolerability
Time frame: Baseline up to 14 days after last dose of study drug (Day 17)
Sponsors and collaborators
Lead sponsor
Janssen Research & Development, LLC
Industry
Registry information
Official study 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
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 22, 2016
- Registry last updated
- Mar 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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