Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: IMBRUVICA (Treatment A) Drug: Ibrutinib (Treatment B) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Ibrutinib [ Time Frame: Day 1 (Pre-dose) up to Day 3 ]
    The Cmax is the maximum observed plasma concentration.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. Maximum Plasma Concentration (Cmax) of IMBRUVICA [ Time Frame: Day 1 (Pre-dose) up to Day 3 ]
    The Cmax is the maximum observed plasma concentration.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841150


Locations
Layout table for location information
United States, Arizona
Tempe, Arizona, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02841150     History of Changes
Other Study ID Numbers: CR108171
54179060CLL1021 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes