A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
研究概览
简要总结
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SPD489 (Lisdexamfetamine dimesylate)
干预措施: SPD489 (Lisdexamfetamine dimesylate) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 70 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 250 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 50 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 100 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 150 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Change From Baseline in Pulse Rate at Day 5: 200 mg
时间窗: Baseline and day 5
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
次要结局
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg(Baseline and Day 5)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg(Day 5 (12-hour sampling period post-dose))
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg(Day 5 (12-hour sampling period post-dose))
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg(Day 5 (12-hour sampling period post-dose))
- Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg(Day 5 (12-hour sampling period post-dose))
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg(Day 5 (12-hour sampling period post-dose))
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg(Baseline and Day 5)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg(Baseline and Day 5)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg(Day 5 (12-hour sampling period post-dose))
- Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg(Day 5 (12-hour sampling period post-dose))
- Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg(Day 5 (12-hour sampling period post-dose))
- Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg(Day 5 (12-hour sampling period post-dose))
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg(Baseline and Day 5)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg(Baseline and Day 5)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg(Baseline and Day 5)
- Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg(Baseline and Day 5)
- Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg(Baseline and Day 5)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg(Baseline and Day 5)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg(Day 5 (12-hour sampling period post-dose))
- Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg(Day 5 (12-hour sampling period post-dose))
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg(Baseline and Day 5)
- Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg(Baseline and Day 5)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg(Baseline and Day 5)
- Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg(Day 5 (12-hour sampling period post-dose))
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg(Baseline and Day 5)
- Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg(Baseline and Day 5)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg(Baseline and Day 5)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg(Baseline and Day 5)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg(Baseline and Day 5)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg(Baseline and Day 5)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg(Baseline and Day 5)
- Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg(Baseline and Day 5)
- Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg(Baseline and Day 5)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg(Baseline and Day 5)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg(Baseline and Day 5)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg(Baseline and Day 5)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg(Baseline and Day 5)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg(Baseline and Day 5)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg(Baseline and Day 5)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg(Baseline and Day 5)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg(Baseline and Day 5)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg(Baseline and Day 5)
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg(Baseline and Day 5)
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg(Baseline and Day 5)