Status:
COMPLETED
A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 e...
Detailed Description
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), sin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02271438
Start Date
October 1 2014
End Date
May 1 2015
Last Update
June 6 2016
Active Locations (1)
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1
Merksem, Belgium