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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02271438
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ibrutinib — DRUG
    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.
  • Moxifloxacin — DRUG
    Participants will receive a single oral dose of 1 moxifloxacin capsule (400 mg) in Treatment D.
  • Ibrutinib-matching placebo — DRUG
    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.
  • Moxifloxacin-matching placebo — DRUG
    Participants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C.

Study Details

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.

Key Dates

Start date
Oct 31, 2014
Status verified
Jun 2016
Primary completion
Apr 30, 2015
Completion
May 31, 2015

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Ibrutinib 840 milligram (mg)
    Participants will receive ibrutinib 840 mg (6\*140 mg capsules) + 6 placebo capsules on Day 1 of Part 1, Period 1.
  • Experimental: Part 1: Ibrutinib 1680 mg
    Participants will receive ibrutinib 1680 mg (12\*140 mg capsules) on Day 1 of Part 1, Period 2.
  • Experimental: Part 2: Treatment A
    Participants will receive ibrutinib, 1680 mg (12\*140 mg capsules) + 1 moxifloxacin-matching placebo capsule Day 1of Part 2.
  • Experimental: Part 2: Treatment B
    Participants will receive ibrutinib, 840 mg (6\*140 mg capsules) + 6 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule.
  • Experimental: Part 2: Treatment C
    Participants will receive placebo (12 ibrutinib-matching placebo capsules + 1 moxifloxacin-matching placebo capsule) Day 1 of Part 2.
  • Experimental: Part 2: Treatment D
    Participants will receive moxifloxacin 400 mg (1 capsule) + 12 ibrutinib-matching placebo capsules Day 1 of Part 2.

Primary Outcome Measure

Change from baseline in QTc interval [ Time Frame: Baseline (predose) up to Day 4 ]

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