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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06520-8048
- Site Reference ID/Investigator# 52162
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group 1 (healthy), Group 2 (schizophrenia)
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One dose of ABT-354
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Brain receptor occupancy
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pharmacokinetic profile
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Earle Bain, MD, Abbott
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- M12-700
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