A Study to Compare the Safety, Tolerability, and Pharmacokinetic Profile of a Single Oral Dose of Pitavastatin 4 mg in Adult Volunteers With Severe Renal Impairment Who Are Not Being Treated With Hemodialysis Versus Healthy Adult Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))
研究概览
简要总结
This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):
The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.
- •Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis [if able to pass urine]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.
- •Subject provides written informed consent before any study-specific evaluation is performed.
- •Subject is able and willing to comply with the protocol and study procedures.
排除标准
- •Subject is on maintenance hemodialysis.
- •Subject has a BMI of >37 kg/m2.
研究组 & 干预措施
Pitavastatin 4mg healthy subjects
Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
干预措施: Pitavastatin 4mg (Drug)
Pitavastatin 4mg renal impaired
Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
干预措施: Pitavastatin 4mg (Drug)
结局指标
主要结局
Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))
时间窗: 48 hours
Area under the curve from start to elimination for Pitavastatin.
次要结局
- Number of Participants With Treatment Emergent Adverse Events(3 Days)