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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841150
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: IMBRUVICA (Treatment A)
    IMBRUVICA (reference treatment), 4*140 milligram (mg), capsules.
    Other Name: Ibrutinib
  • Drug: Ibrutinib (Treatment B)
    Ibrutinib (test treatment), 1*560 mg, tablet.
Study Arms  ICMJE
  • Experimental: Treatment Sequence 1
    Participants will receive treatment A, on Day 1 of Intervention Period 1 followed by treatment B , on Day 1 of Intervention Period 2 followed by treatment A, Day 1 of Intervention Period 3 and then followed by treatment B, on Day 1 of Intervention Period 4. Each intervention Period will be separated by a washout period of 7-9 days.
    Interventions:
    • Drug: IMBRUVICA (Treatment A)
    • Drug: Ibrutinib (Treatment B)
  • Experimental: Treatment Sequence 2
    Participants will receive treatment B, on Day 1 of Intervention Period 1 followed by treatment A, on Day 1 of Intervention Period 2 followed by treatment B, Day 1 of Intervention Period 3 and then followed by treatment A, on Day 1 of Intervention Period 4. Each intervention Period will be separated by a washout period of 7-9 days.
    Interventions:
    • Drug: IMBRUVICA (Treatment A)
    • Drug: Ibrutinib (Treatment B)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02841150
Other Study ID Numbers  ICMJE CR108171
54179060CLL1021 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP