A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

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), single-center, 2-period, sequential design part. It consists of a Screening phase
      (Day-21 to -2), Treatment Period 1 and Treatment Period 2. In treatment period 1, 8
      participants including two women will receive 840 milligram (mg) ibrutinib capsules + 6
      placebo capsules. In treatment period 2, participants will receive 1680 mg ibrutinib
      capsules. Treatment periods will be separated by a Washout period of not less than 7 days. A
      high-fat breakfast will be provided 2 hours before dosing. Blood samples will be collected
      after each dosing for pharmacokinetic assessments.

      Part 2 is a randomized (the study medication is assigned by chance), placebo (an inactive
      substance that is compared with a medication to test whether the medication has a real effect
      in a clinical study) and positive-controlled (participants are assigned to either a
      recognized effective treatment or the study medication), double-blind (neither physician nor
      participant knows the treatment that the participant receives), single dose, and 4-way
      crossover (the same medications are provided to all participants but in a different sequence)
      part. Participants will receive either of the 4 treatments: Treatment A (Ibrutinib 1680 mg +
      moxifloxacin-matching placebo); Treatment B (Ibrutinib 840 mg+ ibrutinib-matching placebo +
      moxifloxacin-matching placebo); Treatment C (ibrutinib-matching placebo +
      moxifloxacin-matching placebo); and Treatment D: (moxifloxacin 400 mg + ibrutinib-matching
      placebo). Each treatment period will be separated by a Washout period of not less than 7
      days. Electrocardiogram (ECG) will be recorded. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Ibrutinib; Moxifloxacin; Ibrutinib-matching placebo; Moxifloxacin-matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Ibrutinib; Moxifloxacin; Cardiac Repolarization; Electrocardiogram; QTc interval