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)

April 15, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-Label, Multi-Center, Sequential Group, Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of JNJ-31001074 After a Single Dose Administration in Pediatric Subjects With Attention-Deficit/Hyperactivity Disorder, 6 to 11 Years Old

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: 3 days of blood and urine sampling
3 days of blood and urine sampling

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
Time Frame: 24 days (includes a 21 day screening phase and a 3-day open-label treatment phase
24 days (includes a 21 day screening phase and a 3-day open-label treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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