A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With Schizophrenia
An Open-Label, Positron Emission Tomography (PET) Study to Evaluate the Brain 5 HT6 Receptor Occupancy by Single Doses of SLV354 in Healthy Male Subjects and Subjects With Stable Schizophrenia
Aperçu de l'étude
Description détaillée
This is an exploratory, open-label PET study designed to examine the relationship between SLV354 plasma concentration and 5-HT6 receptor occupancy in the brain following single oral doses of SLV354 in healthy male subjects and male subjects with stable schizophrenia. A total of up to 22 subjects are to complete the study, including approximately 12 subjects with schizophrenia on a stable dose of an atypical antipsychotic medication. Within 60 days prior to the PET scan, subjects will be screened based on medical history, physical examination, vital signs, ECG, clinical laboratory tests, response to Columbia-Suicide-Severity Rating Scale (C-SSRS) and for schizophrenia subjects only, the diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR). Following Screening, eligible subjects will have a Magnetic Resonance Imaging (MRI) scan, unless one was performed within one year of the PET scan, to delineate the region of interest for the individual PET images. The radiotracer [11C]-QUICS will be used for the PET scans.
All subjects will receive a single oral dose of SLV354. Healthy subjects will have one PET scan prior to and two PET scans after administration of SLV354. Schizophrenia subjects will have two PET scans prior to and one PET scan after administration of SLV354.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06520-8048
- Site Reference ID/Investigator# 52162
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
- Male, age between 18 and 55 years, inclusive.
- Body Mass Index 18 to 30 (healthy) and 18 to 38 (schizophrenia).
- A condition of general good physical health.
- Schizophrenia subjects must have a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR).
- Schizophrenia subjects must be on a stable dose of an atypical antipsychotic for at least 4 weeks prior to Screening.
Exclusion Criteria
- Presence of a metal implant that would preclude a Magnetic Resonance Imaging (MRI) scan.
- Radiation exposure for research purposes within the past year that will exclude participation in the study.
- Significant current suicidal ideation within the past month as evidenced by Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening.
- History of psychiatric diseases or disorders (healthy subjects)
- Unsuitable to receive SLV354 or the radiotracer, [11C]-QUICS.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Group 1 (healthy), Group 2 (schizophrenia)
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One dose of ABT-354
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Brain receptor occupancy
Délai: Study Day -1
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5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy
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Study Day -1
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Brain receptor occupancy
Délai: Study Day 1
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5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy
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Study Day 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pharmacokinetic profile
Délai: Up through Study Day 4
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Maximum observed plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration-time curve (AUC), terminal elimination half-life (t1/2), oral plasma clearance (CL/F)
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Up through Study Day 4
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Earle Bain, MD, Abbott
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M12-700
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