- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00890240
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)
15 april 2010 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 år till 11 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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.
Tidsram: 3 days of blood and urine sampling
|
3 days of blood and urine sampling
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2009
Primärt slutförande (Faktisk)
1 november 2009
Avslutad studie (Faktisk)
1 november 2009
Studieregistreringsdatum
Först inskickad
27 april 2009
Först inskickad som uppfyllde QC-kriterierna
27 april 2009
Första postat (Uppskatta)
29 april 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 april 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 april 2010
Senast verifierad
1 april 2010
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR016183
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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-
Purdue Pharma LPAvslutadAttention Deficit/Hyperactivity DisorderFörenta staterna
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National Taiwan University HospitalNational Science Council, TaiwanOkändAttention Deficit/Hyperactivity DisorderTaiwan
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National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity DisorderTaiwan
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Ornit CohenOkändAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | Attention Deficit Disorder | Attention Deficit Disorders med hyperaktivitet | Attention Deficit Hyperactivity DisordersIsrael
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University of California, Los AngelesNational Institute of Mental Health (NIMH)RekryteringAttention-Deficit Hyperactivity DisorderFörenta staterna
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Ironshore Pharmaceuticals and Development, IncAvslutadAttention-Deficit Hyperactivity DisorderFörenta staterna
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Florida International UniversityAvslutadAttention-deficit/Hyperactivity DisorderFörenta staterna
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National Taiwan University HospitalOkändAttention Deficit/Hyperactivity DisorderTaiwan
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