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Trial record 63 of 307 for:    IBRUTINIB

Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule

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ClinicalTrials.gov Identifier: NCT02877225
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : March 10, 2017
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: Ibrutinib Drug: IMBRUVICA Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of an Ibrutinib 140-mg Tablet Compared to the IMBRUVICA 140-mg Capsule
Actual Study Start Date : August 29, 2016
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : November 11, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Treatment Sequence 1 : ABAB
Participants will receive 140 milligram (mg) of ibrutinib administered as one IMBRUVICA 140-mg oral capsule (Treatment A) in Period 1, 140 mg of ibrutinib administered as one ibrutinib 140-mg oral tablet (Treatment B) in Period 2, then Treatment A in period 3 and then followed by Treatment B in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.
Drug: Ibrutinib
Ibrutinib (test treatment) 140 milligram (mg), tablet.

Drug: IMBRUVICA
IMBRUVICA (reference treatment), 140-mg capsule
Other Name: Ibrutinib

Experimental: Treatment Sequence 2 : BABA
Participants will receive (Treatment B) Period 1, then Treatment A in Period 2, then Treatment B in Period 3 and then followed by Treatment A in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.
Drug: Ibrutinib
Ibrutinib (test treatment) 140 milligram (mg), tablet.

Drug: IMBRUVICA
IMBRUVICA (reference treatment), 140-mg capsule
Other Name: Ibrutinib




Primary Outcome Measures :
  1. Area Under Concentration from time zero to the last quantifiable (AUC [0-last]) [ Time Frame: Predose up to Day 3 ]
    Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

  2. Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) [ Time Frame: Predose 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 (0-last) and C (0-last)/lambda(z); wherein AUC (0-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.

  3. Maximum Observed Analyte Concentration (Cmax) [ Time Frame: Predose up to Day 3 ]
    Maximum observed analyte concentration will be assessed.

  4. Time to Reach Maximum Concentration (Tmax) [ Time Frame: Predose up to Day 3 ]
    Tmax is defined as actual sampling time to reach maximum observed analyte concentration will be assessed.

  5. Apparent Terminal Elimination Halflife (t1/2term) [ Time Frame: Predose up to Day 3 ]
    The elimination halflife (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 calculated as 0.693/apparent terminal elimination rate constant (λz).

  6. Apparent Terminal Elimination Rate Constant (lambda z) [ Time Frame: Predose up to Day 3 ]
    Apparent terminal elimination rate constant, estimated by linear regression using the terminal loglinear phase of the log transformed concentration versus time data.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Approximately 59 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be a man or woman between 18 and 55 years of age, inclusive, at screening
  • 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
  • Body Mass Index (BMI); weight [kilogram (kg)]/height^2 [meter(m)^2)] between 18.0 and 30.0 kg/m2 (inclusive) and body weight not less than 50 kg at screening
  • If a woman, must be of nonchildbearing 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 (>)40 International Units Per Liter (IU/L) or milli-international units per milliliter(mIU/mL), OR, b) Permanently sterile: Permanent sterilization methods include subtotal or total hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), bilateral oophorectomy, and transcervical sterilization
  • Blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
  • Alanine aminotransferase, aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin equal to or lower than the upper limit of normal (per National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE]) at screening

Exclusion Criteria:

  • History of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology or biochemistry at screening as deemed appropriate by the Investigator
  • Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the Investigator
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics
  • Positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening
  • Positive test for human immunodeficiency virus type 1 (HIV-1) or HIV-2 antibodies at screening
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the planned first intake of study drug
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics

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): NCT02877225


Locations
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United States, Arizona
Tempe, Arizona, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02877225     History of Changes
Other Study ID Numbers: CR108174
54179060CLL1022 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017