Overview

A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of JNJ-31001074 in Pediatric Patients (12-17 Years) With Attention Deficit Hyperactivity Disorder (ADHD)

Status:
Completed
Trial end date:
2009-12-01
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 12-17 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