Status:
COMPLETED
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)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders With Hyperactivity
Eligibility:
All Genders
6-11 years
Phase:
PHASE1
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00890240
Start Date
May 1 2009
End Date
November 1 2009
Last Update
April 16 2010
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