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- Sperimentazione clinica NCT01424449
A PET Study in Healthy Volunteers
A Positron Emission Tomography Study in Healthy Male Subjects to Examine the Test-retest Reliability of the D2/3 Agonist Radiotracer [11C]PHNO
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A test-retest (TRT) investigation of [11C]PHNO in human is required to further characterise [11C]PHNO. [11C] PHNO possesses very high affinity for the D3 receptor, and therefore most clinical studies are conducted at D3 occupancies >10%. As [11C]PHNO kinetics in the target brain regions are moderately slow, considerable mass carry over may be present on a 2nd PET scan conducted on the same day. In addition there appears to be a significant displaceable binding component in the cerebellum, which, if not accounted for, will lead to a bias in the quantification of specific [11C]PHNO binding. The aim of this study is therefore to examine the effects of [11C]PHNO mass carry-over and displaceable binding in the cerebellum, on the quantification of [11C]PHNO PET data.
This will be an open label, non-randomised [11C]PHNO PET study using healthy volunteers. Each volunteer will undergo 4 [11C]PHNO PET scans:
1st and 2nd scans; TRT on the same day with a minimal gap between [11C]PHNO injections to examine the effects of PHNO mass carry over, 3rd scan >1 week later to determine the "true" TRT variability and a 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound which allows the highest clinically acceptable blockade of central D2/D3 receptors) and will examine the amount of displaceable binding in the cerebellum, a proposed reference tissue for [11C]PHNO.
The scan data will be quantified as regional volumes of distribution (VT).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, W12 ONN
- GSK Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Healthy as determined by a responsible physician
- Male subjects between 25 and 55 years of age.
- Male subjects must agree to use one of the contraception methods listed
- Capable of giving written informed consent
Exclusion Criteria:
- The subject has a positive pre-study drug/alcohol screen
- The subjects is using or has used regular prescription or non-prescription drugs
- Current or recent (within one year) gastrointestinal disease
- A screening ECG with a QTc value of >450msec and/or a PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements
- Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <100 OR a diastolic blood pressure >90 or <60.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- Any previous or current psychiatric diagnosis listed in DSM-IV Axis I or II
- Any history of suicidal attempts, suicidal ideation or behaviour as assessed by appropriately trained study personnel.
- History of alcohol dependence
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 550 mL within a 56 day period.
- Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
- Family history of cancer
- History of claustrophobia or subjects feeling that he will be unable to lie still on his back in the PET camera for a period of ~2 hours at a time.
- History or presence of a neurological diagnosis
- Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire.
- Unwillingness or inability to follow the procedures outlined in the protocol. -
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: no treatment
Aripiprazole is a D2/D3 antagonist registered in the UK for use in the treatment of schizophrenia.
It allows the highest clinically acceptable blockade of central D2/D3 receptors and will allow us to examine the amount of displaceable binding in the brain - a proposed reference tissue for [11C]PHNO.
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examine the effects of [11C]PHNO mass carry-over and displaceable binding
A 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound which allows the highest clinically acceptable blockade of central D2/D3 receptors)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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volume of distribution
Lasso di tempo: one year
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Regional volume of distribution (VT) in sub-cortical, brainstem and cerebellar regions of interest at each PET scan.
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one year
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi dell'umore
- Disordine depressivo
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti antipsicotici
- Agenti tranquillanti
- Psicofarmaci
- Agenti serotoninergici
- Agenti antidepressivi
- Agonisti della dopamina
- Agenti dopaminergici
- Agonisti del recettore della serotonina 5-HT1
- Agonisti del recettore della serotonina
- Antagonisti del recettore della serotonina 5-HT2
- Antagonisti della serotonina
- Antagonisti del recettore della dopamina D2
- Antagonisti della dopamina
- Aripiprazolo
Altri numeri di identificazione dello studio
- 113549
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su [11C]PHNO
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GlaxoSmithKlineCompletato
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Medical University of ViennaNon ancora reclutamento
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Centre for Addiction and Mental HealthCompletato
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Yale UniversityUniversity of PennsylvaniaCompletatoDisturbo da uso di oppioidiStati Uniti
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Columbia UniversityCompletatoMalattie Neurodegenerative | Sclerosi laterale amiotrofica | Malattia di AlzheimerStati Uniti
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Medical University of ViennaSconosciutoSchizofrenia | Psicosi | SensibilizzazioneAustria
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Hoffmann-La RocheCompletato
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Yale UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletatoComportamento, SaluteStati Uniti
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Columbia UniversityCompletato
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Wendell Yap, MDUniversity of Kansas Medical CenterNon più disponibileCancro alla prostataStati Uniti