NCT02841150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

June 15, 2016

Last Update Submit

March 28, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

  • Maximum Plasma Concentration (Cmax) of Ibrutinib

    The Cmax is the maximum observed plasma concentration.

    Day 1 (Pre-dose) up to Day 3

  • Time to reach maximum concentration (tmax) of Ibrutinib

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    Day 1 (Pre-dose) up to Day 3

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of Ibrutinib

    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

    Day 1 (Pre-dose) up to Day 3

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Ibrutinib

    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.

    Day 1 (Pre-dose) up to Day 3

  • Elimination Rate Constant (Lambda[z]) of Ibrutinib

    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.

    Day 1 (Pre-dose) up to Day 3

  • Terminal Half-Life (t[1/2]) of Ibrutinib

    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).

    Day 1 (Pre-dose) up to Day 3

  • Maximum Plasma Concentration (Cmax) of IMBRUVICA

    The Cmax is the maximum observed plasma concentration.

    Day 1 (Pre-dose) up to Day 3

  • Time to reach maximum concentration (tmax) of IMBRUVICA

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    Day 1 (Pre-dose) up to Day 3

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of IMBRUVICA

    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

    Day 1 (Pre-dose) up to Day 3

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of IMBRUVICA

    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.

    Day 1 (Pre-dose) up to Day 3

  • Elimination Rate Constant (Lambda[z]) of IMBRUVICA

    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.

    Day 1 (Pre-dose) up to Day 3

  • Terminal Half-Life (t[1/2]) of IMBRUVICA

    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).

    Day 1 (Pre-dose) up to Day 3

Secondary Outcomes (1)

  • Number of participants with adverse events and serious adverse events as a measure of safety and tolerability

    Baseline up to 14 days after last dose of study drug (Day 17)

Study Arms (2)

Treatment Sequence 1

EXPERIMENTAL

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)Drug: Ibrutinib (Treatment B)

Treatment Sequence 2

EXPERIMENTAL

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)Drug: Ibrutinib (Treatment B)

Interventions

IMBRUVICA (Treatment A)DRUG

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

Also known as: Ibrutinib
Treatment Sequence 1Treatment Sequence 2
Ibrutinib (Treatment B)DRUG

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

Treatment Sequence 1Treatment Sequence 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Interventions

ibrutinib

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 22, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

US(1)