A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of of JNJ-31001074 in Children (6-11 Years) With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics
      (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the
      body) after a single dose of JNJ-31001074. Up to three dose strengths will be tested in
      patients 6-11 years old with attention deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      This will be an open-label (both the physician and patient know which treatment will be
      administered), multicenter, sequential-group (one group after another), single-dose, Phase I
      study in 6-11 year old patients with attention deficit hyperactivity disorder (ADHD).
      Patients in the first group will be administered a single dose of JNJ-31001074 while they are
      observed and tested (blood and urine samples collected) for a period of time. If they do not
      exhibit any adverse side effects and the data collected is within the predicted safe values,
      the dose will be increased for a new group of patients. Three dose groups are planned (0.015,
      0.045 and 0.15 mg/kg) and up to 18 patients will complete the study. The study consists of a
      screening phase, an open-label treatment phase, and an end-of-study/early withdrawal
      assessments. During screening, patients will be required to give their assent to participate
      (agreement to participate) in the study and parents/guardians will be required to provide
      their consent. Patients will be evaluated to see if they meet selection criteria specified in
      the protocol. Patients who meet the selection criteria at screening will report to the study
      center on the evening prior to Day 1 to confirm that they continue to meet the eligibility
      requirements. If the patient is still eligible, they will be admitted to the study center and
      will be required to fast (no food or beverages) for at least 4 hours prior to their dose. On
      Day 1, a single dose of either 0.015, 0.045 or 0.15 mg/kg of JNJ-31001074 will be
      administered at approximately 8 am, followed by multiple blood sampling and urine collection.
      At the Investigator's discretion, patients may be discharged on Day 3 after the last blood
      and urine samples are taken, or alternatively, they may be discharged on Day 1 after the
      12-hour blood and urine samples are taken. In the latter case, patients will be required to
      return to the study center on Day 2 and Day 3 for additional blood and urine samples.
      Parent(s) may remain at the study center with their child. Patients in the first dose group
      of the study will receive a single 0.015 mg/kg dose of JNJ-31001074. The data obtained from
      the patients in the first dose group will be reviewed prior to the second dose group (0.045
      mg/kg) being started. Data obtained from the patients in the second dose group will be
      reviewed prior to the third dose group (0.15 mg/kg) being started. All patients will be
      required to return to the study site for an end of study / early withdrawal assessment. The
      maximum duration of participation for each patient is expected to be 24 days. Depending on
      their body weight and which dose group they are participating in (0.015 mg/kg, 0.045 mg/kg or
      0.15 mg/kg), patients will be dosed once with a combination of 0.25, 1, 3, and 5 mg tablets
      of JNJ-31001074 administered orally.
    

Intervention name(s): JNJ-31001074
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; JNJ-31001074