A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39393406 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple dose
      administration of JNJ-39393406 in young healthy participants, and subsequently in healthy
      elderly participants.
    

Detailed description: 
      This is a double-blind (neither physician nor participant knows the treatment that the
      participant receives), placebo-controlled (study in which an inactive substance is given to
      one group of participants, while the study medication is given to another group), randomized
      (the study medication is assigned by chance), and multiple ascending dose (participants will
      receive multiple doses of study medication and the dose level is subsequently escalated in
      further groups) study. This study will consist of screening phase (between 21 and 2 days
      prior to dose administration), a double-blind treatment phase (Part A - 7 days and Part B -
      13 days), and a follow-up phase (within 7 to 14 days after last dose administration). In Part
      A of the multiple ascending dose study approximately 40 young healthy male participants will
      be randomly allocated to 5 cohorts (group of individuals with similar characteristics) to
      receive single daily doses of either JNJ-39393406 or placebo for 7 consecutive days. After
      each dose level, safety, tolerability, and pharmacokinetic (PK) profile (explores what the
      body does to a medication) of the dose level will be evaluated and the next dose level will
      be escalated considering the safety and tolerability data. In Part B of the study
      approximately 48 elderly healthy male and female participants will be randomly allocated to
      A, B, and C cohorts to receive single daily doses of either JNJ-39393406 or placebo for 13
      consecutive days. Dose levels in Part B will be selected based on the PK data from Part A. In
      both Part A and Part B of the study the dose levels will be increased only after acceptable
      safety and tolerability data will be obtained. Safety evaluations will include assessments of
      adverse events, clinical laboratory tests, 24-hour creatinine clearance, Holter monitoring,
      telemetry, electrocardiogram, vital signs, physical examination, and neurological
      examination. The study duration for each participant will be approximately 8 weeks.
    

Intervention name(s): JNJ-39393406; Placebo
Intervention type(s): Drug; Other
Intervention description(s): In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.; In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; JNJ-39393406; Safety; Tolerability; Pharmacokinetics