A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-40411813 in Male and Female Elderly Patients
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the
      body does to the study medication) and pharmacodynamics (the study of the action or effects
      the study medication has on the body) of single- and multiple, escalating oral doses of
      JNJ-40411813.
    

Detailed description: 
      This is a double-blind (neither physician nor participants knows the treatment that the
      participant receives), randomized (study medication is assigned by chance),
      placebo-controlled (an inactive substance is compared with a medication to test whether the
      medication has a real effect in a clinical study), single- and multiple ascending dose study.
      This study consists of 3 phases: screening phase, treatment phase, and follow-up phase. This
      study will be conducted in 2 cohorts (groups) (Cohort 1: JNJ-40411813 50 mg and Cohort 2:
      JNJ-40411813 100 mg) and each cohort consists of 2 periods (Period 1: single dose and Period
      2: multiple doses). Approximately 36 participants will be enrolled in this study (18
      participants will be enrolled in each cohort) to receive JNJ-40411813 or placebo in 2:1
      ratio. If safety/tolerability and pharmacokinetic results profile is favorable for single
      dose of JNJ-40411813, multiple dose administration will follow. Safety will be evaluated by
      the assessment of adverse events, vital signs, schellong test (a test for circulatory
      function), 12-lead electrocardiogram, physical examination, neurological examination (to
      measure mental status, motor examination, reflexes, sensory, gait and cranial nerves),
      vertigo (giddiness) symptom, and clinical laboratory tests which will be monitored throughout
      the study. The total duration of study participation for a participant will be 9 weeks.
    

Intervention name(s): JNJ-40411813 50 mg; JNJ-40411813 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohort 1: Participants will receive 50 mg of JNJ-40411813 (2 capsules X 25 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth).; Cohort 2: Participants will receive 100 mg of JNJ-40411813 (1 capsule X 100 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth).; Cohort 1: Participants will receive placebo once a day on Day 1 for Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 for Period 2; Cohort 2: Participants will receive placebo once a day on Day 1 for Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 for Period 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; JNJ-40411813; Positive allosteric modulator