To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the
      drug) and safety of JNJ-54452840 in healthy participants.
    

Detailed description: 
      This is a Phase 1, randomized (the study treatment is assigned by chance), double-blind
      (neither physician nor participant knows the treatment received), placebo-controlled (one of
      the study treatments is inactive), four-way cross-over study (method used to switch
      participants from one treatment arm to another in a clinical trial) conducted in healthy male
      Japanese and Caucasian participants. The study will be conducted in 3 parts; a screening
      phase (up to 28 days), a double-blind treatment phase (28 days), and a follow-up phase
      (approximately 21 to 28 days). The study will be conducted in 2 groups (Group A consists of
      16 Japanese participants; Group B consists of 16 Caucasian participants) over 4 treatment
      periods. On Day 1 of Period 1, approximately 16 eligible Japanese participants and the same
      number of eligible Caucasian participants will be randomly assigned to 1 of 4 treatment
      sequences and will receive the 4 intravenous treatments JNJ-54452840 20 mg, JNJ-54452840 80
      mg, JNJ-54452840 240 mg, and placebo across the treatment periods according to the order
      specified by the randomization schedule.

      Participants will come to the study center each time they receive study medication and will
      be discharged from the study center 24 hours after dosing during each treatment period after
      satisfactory review of all clinical safety measures. Blood samples will be drawn at time
      points during the treatment and follow-up periods for participants in both Group A and Group
      B of the study. Participants will return to the study center for a follow-up visit within
      approximately 7 to 10 days after the last study procedure in the last treatment period for
      safety assessments, followed by another visit within approximately 21 to 28 days for
      assessment of anti -beta-1-AR (adrenergic receptor) auto-antibodies in blood (auto-antibodies
      targeting the human beta-1-AR antibody). If anti-beta-1-AR auto-antibodies are detected at
      this second follow-up visit, additional testing will be performed every 3 months until
      autoantibody levels fall below the level of detection of the assay or for 1 year, whichever
      occurs earlier. Participants in Group A and Group B will be involved in the study for
      approximately 12 weeks and up to 1 year if they develop anti -beta-1-AR auto-antibodies .
      Safety of the participants will be monitored throughout the study.
    

Intervention name(s): JNJ-54452840; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg; Single matching intravenous dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Japanese; Caucasian; Male; Pharmacokinetic; JNJ-54452840