The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram (ECG) in healthy adults.
The study consists of 2 parts: Part 1 and Part 2. Part 1 is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving), single-center, 2-period, sequential design part. It consists of a Screening phase (Day-21 to -2), Treatment Period 1 and Treatment Period 2. In treatment period 1, 8 participants including two women will receive 840 milligram (mg) ibrutinib capsules + 6 placebo capsules. In treatment period 2, participants will receive 1680 mg ibrutinib capsules. Treatment periods will be separated by a Washout period of not less than 7 days. A high-fat breakfast will be provided 2 hours before dosing. Blood samples will be collected after each dosing for pharmacokinetic assessments. Part 2 is a randomized (the study medication is assigned by chance), placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and positive-controlled (participants are assigned to either a recognized effective treatment or the study medication), double-blind (neither physician nor participant knows the treatment that the participant receives), single dose, and 4-way crossover (the same medications are provided to all participants but in a different sequence) part. Participants will receive either of the 4 treatments: Treatment A (Ibrutinib 1680 mg + moxifloxacin-matching placebo); Treatment B (Ibrutinib 840 mg+ ibrutinib-matching placebo + moxifloxacin-matching placebo); Treatment C (ibrutinib-matching placebo + moxifloxacin-matching placebo); and Treatment D: (moxifloxacin 400 mg + ibrutinib-matching placebo). Each treatment period will be separated by a Washout period of not less than 7 days. Electrocardiogram (ECG) will be recorded. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Participants will receive a single oral dose of 12 capsules (12\*140 mg capsules) of ibrutinib in Treatment A and 6 capsules (4 6\*140 mg capsules) of ibrutinib in Treatment B.
Participants will receive a single oral dose of 1 moxifloxacin capsule (400 mg) in Treatment D.
Participants will receive a single oral dose of 12 ibrutinib-matching placebo capsules in Treatment B and 6 ibrutinib-matching placebo capsules in Treatment C and D.
Unnamed facility
Merksem, Belgium
Change from baseline in QTc interval
The QTc interval, as measured by electrocardiograms will evaluate the potential effect of ibrutinib on QTc interval duration.
Time frame: Baseline (predose) up to Day 4
Number of Participants with Adverse events
Time frame: Up to Day 12 of the follow-up period
Change from baseline in RR interval
The RR interval is the portion between two consecutive R waves in the electrocardiogram.
Time frame: Baseline (predose) up to Day 4
Change from baseline in heart rate
Time frame: Baseline (predose) up to Day 4
Change from baseline in PR interval
The PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).
Time frame: Baseline (predose) up to Day 4
Change from baseline in QRS interval
The QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.
Time frame: Baseline (predose) up to Day 4
Plasma concentration of ibrutinib following administration of a single dose
Plasma concentrations of ibrutinib are used to evaluate when the highest concentration is achieved in the body and how long it stays in the body.
Time frame: Predose (before tablet intake), up to 72 hours after dose
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Participants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C.
Plasma concentration of the Metabolite, PCI-45227, following administration of a single dose of ibrutinib
Plasma concentrations of the metabolite, PCI-45227, are used to evaluate when the highest concentration is achieved in the body and how long it stays in the body.
Time frame: Predose (before tablet intake), up to 72 hours after dose
Plasma concentration of moxifloxacin following administration of a single dose
Plasma concentrations of moxifloxacin are used to evaluate when the highest concentration is achieved in the body and how long it stays in the body.
Time frame: Predose (before tablet intake), up to 72 hours after dose