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)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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