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Completed

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tempe, Arizona, United States

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)

Drug

IMBRUVICA (reference treatment), 4*140 milligram (mg), capsules.

Other names: Ibrutinib

Ibrutinib (Treatment B)

Drug

Ibrutinib (test treatment), 1*560 mg, tablet.

Primary outcomes

  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 outcomes

  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)

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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