A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
研究概览
简要总结
The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 50 years, inclusive, at the time of consent.
- •Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
- •Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
- •Ability to swallow all investigational product.
- •A minimum of 1 bowel movement per day.
排除标准
- •History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
- •Current or relevant history of physical or psychiatric illness.
- •Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
- •Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
- •Known history of alcohol or other substance abuse within the last year.
- •Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
- •Within 30 days prior to the dose of investigational product:
- •Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
- •Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
- •Have had any substantial changes in eating habits, as assessed by the investigator.
- •Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
- •Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
- •A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
- •Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
- •A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
- •Use of tobacco in any form
- •Routine consumption of more than 2 units of caffeine per day
- •Current use of any medication including over-the-counter, herbal, or homeopathic preparations
- •An inability to follow a standardized diet and meal schedule or inability to fast
- •Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
- •Exposure to clinically significant radiation within 12 months prior to the dose of investigational product
研究组 & 干预措施
Experimental Drug
single oral dose radiolabelled 50mg of SHP626
干预措施: SHP626 (Drug)
Experimental Drug
single oral dose radiolabelled 50mg of SHP626
干预措施: 5.95 μCi RAD (Radiation)
结局指标
主要结局
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
时间窗: Day 1 to day 10
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
时间窗: Day 1 to day 10
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
时间窗: Day 1 to Day 10
Total radioactivity (RAD) in whole blood and plasma
时间窗: Day 1 to day 10
To determine the total RAD in urine and feces.
时间窗: Day 1 to day 10
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
时间窗: Day 1 to Day 10
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
时间窗: Day 1-10
Excreted Percent of RAD recovered in urine over the dosing interval
时间窗: Day 1-10
Renal Clearance (CLR ) of 50mg [14C]-SHP626
时间窗: Day 1 -10
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
时间窗: Day 1-10
Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
时间窗: Day 1-10
Excreted Percent of RAD recovered in stool over the dosing interval
时间窗: Day 1-10
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
时间窗: Day 1 to Day 10
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
时间窗: Day 1-10
次要结局
- Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification(Day 1 to day 10)
- Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification(Day 1 to day 10)
- Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting(Day 1 to day 10)
- Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings(Screening to day 7)
- Changes from baseline in vital signs(Screening to day 7)
- Changes from baseline in ECGs(Screening to day 7)
- Changes from baseline in coagulation(Screening to day 7)
- Changes in baseline in urinalysis(Screening to day 7)
- Changes in baseline in chemistry(Screening to day 7)
- Changes from baseline in hematology(Screening to day 7)