- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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London, Vereinigtes Königreich, W12 ONN
- GSK Investigational Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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. -
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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volume of distribution
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Stimmungsschwankungen
- Depression
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Antipsychotische Mittel
- Beruhigende Agenten
- Psychopharmaka
- Serotonin-Agenten
- Antidepressiva
- Dopamin-Agonisten
- Dopamin-Agenten
- Serotonin-5-HT1-Rezeptor-Agonisten
- Serotonin-Rezeptor-Agonisten
- Serotonin-5-HT2-Rezeptorantagonisten
- Serotonin-Antagonisten
- Dopamin-D2-Rezeptor-Antagonisten
- Dopamin-Antagonisten
- Aripiprazol
Andere Studien-ID-Nummern
- 113549
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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