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

NCT02271438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-06-06

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Ibrutinib

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.

DRUG

Moxifloxacin

Participants will receive a single oral dose of 1 moxifloxacin capsule (400 mg) in Treatment D.

DRUG

Ibrutinib-matching placebo

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.

DRUG

Moxifloxacin-matching placebo

Participants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271438 on ClinicalTrials.gov