A Phase 1 interventional study of IMBRUVICA (Treatment A) and Ibrutinib (Treatment B) in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other
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.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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)
IMBRUVICA (reference treatment), 4\*140 milligram (mg), capsules.
Also known as: Ibrutinib
Ibrutinib (test treatment), 1\*560 mg, tablet.
Maximum Plasma Concentration (Cmax) of Ibrutinib
The Cmax is the maximum observed plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Day 1 (Pre-dose) up to Day 3
Maximum Plasma Concentration (Cmax) of IMBRUVICA
The Cmax is the maximum observed plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Day 1 (Pre-dose) up to Day 3
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)
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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