NCT01959399已完成1 期
A Phase 1, Open-Label, Single-Sequence Drug Interaction Study to Evaluate the Effect of Multiple-Dose ASP015K on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter for rosuvastatin: AUCinf
研究概览
简要总结
The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the pharmacokinetics of rosuvastatin in healthy adult male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.
- •Asian subject must be first generation Japanese born in Japan with both parents and four grandparents of Japanese descent and have resided outside of Japan for 5 years or less, or first generation Chinese born in China with both parents and four grandparents of Chinese descent and have resided outside of China for 5 years or less, or first generation Korean born in Korea with both parents and four grandparents of Korean descent and have resided outside of Korea for 5 years or less.
- •Non-Asian subject is self-reported as White, Black or African American, and Hispanic or Latino.
- •Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses] prior to screening or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
- •Female subject must have a negative pregnancy test at screening and day -
- •Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
- •Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
- •Male subject must not donate sperm from screening and throughout the study period and for 90 days after final study drug administration.
- •Subject agrees not to participate in another investigational study while on treatment.
- •Subject must be capable of swallowing multiple tablets.
排除标准
- •Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
- •Subject has a known or suspected hypersensitivity to rosuvastatin, ASP015K, or any components of the formulations used.
- •Subject has had a previous intolerance or adverse reaction to a statin therapy.
- •Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Subject has any history or evidence of any clinically significant cardiovascular, gastro intestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator or designee.
- •Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day -
- •Subject has a mean pulse < 40 or > 90 beats per minute (bpm); mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for at least 5 minutes at screening and day -
- •Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT) and intermittent acetaminophen (to a maximum of 2 g/day).
- •Subject has smoked or has used tobacco-containing products and nicotine or nicotine containing products in the past 6 months prior to screening.
- •Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- •Subject has a positive test for alcohol, drugs of abuse, or cotinine at screening or day -
- •Subject has used any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to day -
- •Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic check-in on day -
- •Subject has a positive serology test for hepatitis B surface antigen (HBsAg) (total), anti hepatitis A virus (Ig M), anti-hepatitis C virus, anti-hepatitis B core, or anti HIV type 1 or type 2 at screening.
- •Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
- •Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test at screening.
- •Subject has received any vaccine within 60 days prior to study drug administration.
- •Subject has had major gastrointestinal surgery or has a medical condition which may inhibit the absorption and/or metabolism of study drug.
- •Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville blood oranges (including marmalade), star fruit, or any products containing these items from 72 hours prior to day -1 and throughout the duration of the study.
研究组 & 干预措施
ASP015K + rosuvastatin
Experimental
干预措施: ASP015K (Drug)
ASP015K + rosuvastatin
Experimental
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Pharmacokinetic parameter for rosuvastatin: AUCinf
时间窗: Days 1 and 10
Area under the curve to the infinity
Pharmacokinetic (PK) parameter for rosuvastatin: AUClast
时间窗: Days 1 and 10
Area under the curve to the last measurable time
Pharmacokinetic parameter for rosuvastatin: Cmax
时间窗: Days 1 and 10
Maximum Concentration
次要结局
- Composite of PK parameters for ASP015K: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax), apparent volume of distribution (Vz/F), apparent plasma clearance at steady (CLss/F)(Days 9 and 10)
- Pharmacokinetic parameter for ASP015K: Ctrough(Days 7-10)
- Safety assessed adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examination and vital sign measurements(Day 1-14)
- Composite of pharmacokinetic parameters for ASP015K metabolites: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax)(Days 9 and 10)
- Composite of pharmacokinetic parameters for rosuvastatin: time after dosing when Cmax occurs (tmax), apparent-terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent plasma clearance (CL/F)(Days 1 and 10)
- Pharmacokinetic parameter for ASP015K metabolites: Ctrough(Days 7-10)
研究者
研究点 (1)
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