A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Particiants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of JNJ-54861911 on the QT/QTc intervals
      in healthy participants, when administered at therapeutic (50 milligram [mg] once-daily) and
      supratherapeutic (150 mg once-daily) doses for 7 days.
    

Detailed description: 
      This is a Phase 1, double blind (a medical research study in which neither the researchers
      nor the participants know what treatment the participants is receiving), randomized (study
      drug assigned by chance), placebo and positive-controlled, multiple-dose, 4-way crossover
      (method used to switch participants from one study group to another) study. The study
      consists of 3 parts: Screening period (Days -21 to -2), Double-blind treatment period and
      End-of-study/early withdrawal assessment period (9 to 13 days after last dose). Treatment
      period will comprise of 4 treatment regimens each consisting of a baseline assessment and a
      treatment regime (Days -1 to 9). The participants will be randomly assigned to 1 of 4
      treatment sequence groups (ADBC, BACD, CBDA, and DCAB) based on a computer-generated
      randomization schedule and will receive the following 4 treatments in the order specified by
      the randomization: Treatment A (JNJ-54861911, 50 milligram (mg) once daily for 7 days plus
      moxifloxacin-matched placebo on Day 7); Treatment B (JNJ-54861911, 150 mg once daily for 7
      days plus moxifloxacin-matched placebo on Day 7); Treatment C (JNJ-54861911-matched placebo
      once daily for 7 days plus moxifloxacin-matched placebo on Day 7); Treatment D
      (JNJ-54861911-matched placebo once daily for 7 days plus moxifloxacin 400 mg on Day 7). Each
      treatment period will be separated by a washout period of at least 6 - 10 days. Total
      duration of study for a participant will be 93 days. Change from Baseline in QT/QTc intervals
      at Day 7 will be evaluated as primary end point. Participant's safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-54861911-Therapeutic Dose; JNJ-54861911 - Supratherapeutic Dose; JNJ-54861911-Matched Placebo; Moxifloxacin; Moxifloxacin Matched Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.; JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.; JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.; Moxifloxacin 400 mg on Day 7 in all treatment sequence.; Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.
Other intervention name(s): RSC-385896; MTS-0385896A; RSC-385896; MTS-0385896A
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JNJ-54861912; RSC-385896; MTS-0385896A; Phase 1; Moxifloxacin; Placebo; Healthy