A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of SSP-004184AQ (Magnesium Salt) to SSP-004184SS (Disodium Salt) Each Administered as a Single Dose and as Two Doses of SSP-004184 (Free Acid) in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose
研究概览
简要总结
This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Age 18-65 years
- •Must be considered "healthy".
- •Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range
排除标准
- •Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
- •Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period
- •Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
- •Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
- •History of alcohol or other substance abuse within the last year.
- •A positive screen for alcohol or drugs of abuse at the Screening Visit.
- •Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
- •Twelve-lead ECG demonstrating QTc >450msec at screening.
- •Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
- •Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
- •A positive HIV antibody screen, HBsAg, or HCV antibody screen.
- •Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.
研究组 & 干预措施
SSP-004184AQ (single dose)
40 mg/kg (oral capsule form) given once on Day 1
干预措施: SSP-004184AQ (Drug)
SSP-004184SS (single dose)
21.8 mg/kg (oral capsule form) given once on Day 1
干预措施: SSP-004184SS (Drug)
SSP-004184AQ (2 doses)
40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1
干预措施: SSP-004184AQ (Drug)
SSP-004184SS (2 doses)
21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1
干预措施: SSP-004184SS (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose
时间窗: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose
时间窗: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body
Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose
时间窗: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated
次要结局
- Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses(Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.)
- Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses(Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.)
- Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses(Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.)