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)

NCT00890240 | Completed Phase 1

• 1 other identifier: CR016183
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; JNJ-31001074

Outcome Measures

Primary Outcomes (1)

• The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of JNJ-31001074 after a single dose administration of JNJ-31001074 in pediatric patients with ADHD, 6 to 11 years of age, inclusive.

  3 days of blood and urine sampling

Secondary Outcomes (1)

• Incidence and type of adverse events and changes in clinical laboratory results, electrocardiograms(ECGs),physical examination,vital signs,Clinical Global Impression of Severity of Illness(CGI-S) scale and Columbia-Suicide Severity Rating Scale (C-SSRS)

  24 days (includes a 21 day screening phase and a 3-day open-label treatment phase

Interventions

JNJ-31001074 DRUG

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of ADHD
• Height and weight within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex
• Clinically stable with no changes in the management of ADHD for at least 1 week prior to screening
• Clinical Global Impression of Severity of Illness (CGI-S) score must be 3 or less at screening
• Children who are capable of providing assent (typically 7 years of age and older) must sign an assent form

You may not qualify if:

• History of or current clinically significant medical illness
• DSM-IV diagnosis of psychiatric disorder other than ADHD
• Have taken methylphenidate, amphetamine, or other stimulant medications within 5 half-lives before screening or atomoxetine within 30 days of screening
• Use of any prescription or nonprescription medication except for acetaminophen within 14 days before planned dosing of the study drug
• Positive test for drugs of abuse

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

bavisant

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 16, 2010

Record last verified: 2010-04