- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00783783
CYP2D6 Pharmacogenetics in Risperidone-Treated Children
CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Subjects will include up to 41 risperidone-treated children and adolescents with psychiatric or neurodevelopmental (ND) disorders who participated in one of two previous risperidone pharmacokinetics investigations.
To have a larger sample of poor metabolizer subjects, we plan to enroll at least 8 additional subjects who are on stable treatment with risperidone, and perform risperidone pharmacokinetics analyses. Prospectively enrolled subjects (n = 8) will be CYP2D6 poor metabolizers and will include White / Caucasian subjects, of any socioeconomic status, and will be recruited from inpatients or outpatients at Cincinnati Children's Hospital
Beskrivelse
Inclusion Criteria:
- Previous risperidone PK study participation (CCHMC, Rainbow Babies and Children's Hospital or OSU)
- CYP2D6 PM predicted phenotype
- Actively taking risperidone
- Under 18 years of age at time of enrollment
- Signed, dated informed consent forms
Exclusion Criteria:
- Investigators are unable to contact the subject/legal guardian(s)
- Subject is no longer taking risperidone
- CYP2D6 predicted phenotype other than PM
- Subject is non-White, with respect to race, for PK study participation
- Subject is 18 years of age or older
- Subject is less than 5 years of age
- Subject is pregnant at the time of the full PK study
- Subject/legal guardian unwilling or unable to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Poor metabolizers
Patients with CYP2D6 genotypes predictive of poor metabolizer phenotype
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Non poor metabolizers
Patients with CYP2D6 genotypes predictive of intermediate, extensive, or ultra-rapid metabolizer phenotypes
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
association of common CYP2D6 polymorphisms with risperidone area under the curve
Tidsramme: pre-dose (sample 1 = 0-30 minutes before first oral dose), and three at well-timed post-dose points (sample 2 = 15-30 minutes after dose; sample 3 = 60-90 minutes after dose; sample 4 = 4-6 hours after dose)
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pre-dose (sample 1 = 0-30 minutes before first oral dose), and three at well-timed post-dose points (sample 2 = 15-30 minutes after dose; sample 3 = 60-90 minutes after dose; sample 4 = 4-6 hours after dose)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Shannon N Saldana, PharmD, MS, Children's Hospital Medical Center, Cincinnati
Publikationer og nyttige links
Generelle publikationer
- Aman MG, Vinks AA, Remmerie B, Mannaert E, Ramadan Y, Masty J, Lindsay RL, Malone K. Plasma pharmacokinetic characteristics of risperidone and their relationship to saliva concentrations in children with psychiatric or neurodevelopmental disorders. Clin Ther. 2007 Jul;29(7):1476-86. doi: 10.1016/j.clinthera.2007.07.026.
- Cabovska B, Cox SL, Vinks AA. Determination of risperidone and enantiomers of 9-hydroxyrisperidone in plasma by LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jun 1;852(1-2):497-504. doi: 10.1016/j.jchromb.2007.02.007. Epub 2007 Feb 15.
- Sherwin CM, Saldana SN, Bies RR, Aman MG, Vinks AA. Population pharmacokinetic modeling of risperidone and 9-hydroxyrisperidone to estimate CYP2D6 subpopulations in children and adolescents. Ther Drug Monit. 2012 Oct;34(5):535-44. doi: 10.1097/FTD.0b013e318261c240.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2008-0659
- SPR104683
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