NCT01124747已完成1 期
An Open-Label Study to Evaluate the Disposition of 14C-Labeled ASP1585 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Excretion of radioactivity in urine
研究概览
简要总结
The objective of this study is to assess the systemic disposition of ASP1585 after oral administration of 14C-labeled drug in healthy male subjects.
详细描述
Subjects will receive study drug for 18 days with a radioactive dose of study drug given on Day 15. Blood, urine and feces will be collected to confirm recovery of radioactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive and minimum body weight 45 kg
- •Agrees to sexual abstinence or to use a highly effective form of birth control which includes a barrier method throughout the study
- •In good health
排除标准
- •History of any clinically significant disease
- •History of bowel obstruction, swallowing disorders, gastrointestinal disorders, gastrointestinal surgery, actively bleeding hemorrhoids, or gastric/duodenal ulcers
- •Irregular bowel habits (<1 bowel movement per day)
- •Clinically significant illness within 30 days
- •Received any drug or medicine (prescription or over-the-counter), including topical medications, complementary and alternative medicines and vitamin and mineral supplements within 14 days prior to the first dose of study drug
- •Received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to screening
- •Consumes >10 units of alcohol per week or history of alcoholism or drug/chemical abuse within past 2 years
- •Smokes cigarettes or other nicotine-containing products
- •Anticipates an inability to abstain from alcohol use for 48 hours prior to first dose of study drug or from grapefruit, Seville oranges, star fruit or products containing these items from 72 hours prior to first dose of study drug until end of study
- •Positive drug or alcohol screen at Screening or Day -1
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) value of >2x upper limit of normal at Screening or Day -1
- •Known positive for human immunodeficiency virus (HIV), Hepatitis A, Hepatitis B or Hepatitis C
- •Unwilling or unable to swallow large numbers of capsules
- •Significant blood loss, donated one unit of blood or more, or received a transfusion of any blood or blood product within 60 days or donated plasma within 7 days prior to Day -1
- •Known cumulative radiation exposure >5 rems for the whole body, active blood forming organs, ocular lens, and gonads, and >15 rems for other organs
- •Has had nuclear medicine procedures, computed tomography scans, or significant x-rays (other than dental) within the past 12 months, has received radiolabeled material within the last 6 months, or has had significant occupational radiation exposure
- •Has participated in a radiolabled study within the last 6 months or participated in more than one radiolabeled study within the last 12 months
研究组 & 干预措施
ASP1585 and 14C-Labeled ASP1585
Experimental
干预措施: ASP1585 (Drug)
ASP1585 and 14C-Labeled ASP1585
Experimental
干预措施: 14C-Labeled ASP1585 (Drug)
结局指标
主要结局
Excretion of radioactivity in urine
时间窗: Day 15 and up to Day 24
Excretion of radioactivity in feces
时间窗: Day 15 and up to Day 24
次要结局
- Radioactivity assessment through analysis of blood samples(Day 15 and up to Day 24)
研究者
相似试验
终止
2 期
An Open-Label Study of Apabetalone in Covid InfectionCOVID-19 InfectionNCT04894266Resverlogix Corp1
已完成
1 期
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 AntigenAdvanced MalignanciesAdvanced CancerNCT04837196Astellas Pharma Global Development, Inc.24
已完成
1 期
Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)NCT02181660Astellas Pharma Inc24
已完成
1 期
A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male VolunteersHealthyNCT01157000Johnson & Johnson Pharmaceutical Research & Development, L.L.C.9
已完成
3 期
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung CancerNon-Small-Cell Lung CancerNCT00049998GlaxoSmithKline760