Overview

A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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