A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls
研究概览
简要总结
This is a two part study to compare the PK of preladenant administered to participants with CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of participants with moderate CRI and participants with mild CRI to healthy participants. The primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe, moderate or mild CRI is similar to that of matched healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index (BMI) between 19 to 34 kg/m^2, inclusive
- •Has mild to severe CRI and not on dialysis (Participants with normal renal function are to be matched to subjects with renal impairment)
- •Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges
- •Free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions)
排除标准
- •Females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- •Had a renal transplant or are on dialysis
- •Has a history of any infectious disease within 4 weeks
- •Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- •Has donated blood or had a blood transfusions in the past 60 days
- •Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial
- •Has a history of malignancy
- •Has evidence of suicidality or is at risk for self-harm or harm to others
研究组 & 干预措施
Part 1: Severe Renal Impairment
Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
干预措施: Preladenant (Drug)
Part 2: Moderate Renal Impairment
Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
干预措施: Preladenant (Drug)
Part 2: Mild Renal Impairment
Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
干预措施: Preladenant (Drug)
Part 1: Normal Renal Function
Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
干预措施: Preladenant (Drug)
Part 2: Normal Renal Function
Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
干预措施: Preladenant (Drug)
结局指标
主要结局
AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls
时间窗: Pre-dose to 48 hours post-dose
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls
时间窗: Pre-dose to 48 hours post-dose
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls
时间窗: Pre-dose to 48 hours post-dose
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
次要结局
未报告次要终点