A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single-Dose, Four-Way Crossover Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Subjects
3 other identifiers
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Oct 2014
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 6, 2016
June 1, 2016
6 months
October 20, 2014
June 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in QTc interval
The QTc interval, as measured by electrocardiograms will evaluate the potential effect of ibrutinib on QTc interval duration.
Baseline (predose) up to Day 4
Number of Participants with Adverse events
Up to Day 12 of the follow-up period
Secondary Outcomes (7)
Change from baseline in RR interval
Baseline (predose) up to Day 4
Change from baseline in heart rate
Baseline (predose) up to Day 4
Change from baseline in PR interval
Baseline (predose) up to Day 4
Change from baseline in QRS interval
Baseline (predose) up to Day 4
Plasma concentration of ibrutinib following administration of a single dose
Predose (before tablet intake), up to 72 hours after dose
- +2 more secondary outcomes
Study Arms (6)
Part 1: Ibrutinib 840 milligram (mg)
EXPERIMENTALParticipants will receive ibrutinib 840 mg (6\*140 mg capsules) + 6 placebo capsules on Day 1 of Part 1, Period 1.
Part 1: Ibrutinib 1680 mg
EXPERIMENTALParticipants will receive ibrutinib 1680 mg (12\*140 mg capsules) on Day 1 of Part 1, Period 2.
Part 2: Treatment A
EXPERIMENTALParticipants will receive ibrutinib, 1680 mg (12\*140 mg capsules) + 1 moxifloxacin-matching placebo capsule Day 1of Part 2.
Part 2: Treatment B
EXPERIMENTALParticipants will receive ibrutinib, 840 mg (6\*140 mg capsules) + 6 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule.
Part 2: Treatment C
EXPERIMENTALParticipants will receive placebo (12 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule) Day 1 of Part 2.
Part 2: Treatment D
EXPERIMENTALParticipants will receive moxifloxacin 400 mg (1 capsule) + 12 ibrutinib-matching placebo capsules Day 1 of Part 2.
Interventions
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.
Participants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C.
Eligibility Criteria
You may qualify if:
- Must sign an informed consent document indicating they understand the purpose of the study and procedures
- Must have a body mass index (BMI) of between 18 and 30 kg/m\^2, inclusive
- Must have a body weight of not less than 50 kg
- Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
- Must have an average of triplicate 12-lead ECG recordings, completed within 5 minutes total, consistent with normal cardiac conduction and function
You may not qualify if:
- History of or current clinically significant medical illness
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram
- History of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, and heart blocks
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements
- Donated blood or blood products or had substantial loss of blood within 3 months before screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Merksem, Belgium
Related Publications (1)
de Jong J, Hellemans P, Jiao JJ, Huang Y, Mesens S, Sukbuntherng J, Ouellet D. Ibrutinib does not prolong the corrected QT interval in healthy subjects: results from a thorough QT study. Cancer Chemother Pharmacol. 2017 Dec;80(6):1227-1237. doi: 10.1007/s00280-017-3471-x. Epub 2017 Oct 28.
PMID: 29080970DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 22, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
June 6, 2016
Record last verified: 2016-06