An Open-Label, Parallel-Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 Following Oral Administration and With a Food Effect Panel
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- The safety and tolerability
研究概览
简要总结
This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and urine albumin levels) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of nephropathy as well as control hypertension.
详细描述
This is an open-label, parallel-group, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 following a single dose administration of KBP-5074 with and without food. The study includes 2 parts.
Part 1: Pharmacokinetics from each dose cohort will be characterized before initiation of dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074.
Part 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed conditions. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074 under fed conditions.
Serum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.
The urine samples will be also used for quantitative determination of urinary albumin in both Part 1 and Part 2.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2, no significant medical history, normal renal function and in good general health
排除标准
- •Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; A history of prescription drug abuse, or illicit drug use within 6 months prior to screening
研究组 & 干预措施
KBP-5074: Cohort 1
Healthy Volunteers will receive one dose of KBP-5074
干预措施: KBP-5074 (Drug)
KBP-5074: Cohort 2
Healthy Volunteers will receive one dose of KBP-5074
干预措施: KBP-5074 (Drug)
KBP-5074: Cohort 3
Healthy Volunteers will receive one dose of KBP-5074
干预措施: KBP-5074 (Drug)
KBP-5074: Cohort 4
Healthy Volunteers will receive one dose of KBP-5074
干预措施: KBP-5074 (Drug)
KBP-5074: Cohort 5
Healthy Volunteers will receive one dose of KBP-5074
干预措施: KBP-5074 (Drug)
KBP-5074: Fed Group
Healthy Volunteers will receive one dose of KBP-5074
干预措施: KBP-5074 (Drug)
结局指标
主要结局
The safety and tolerability
时间窗: 14 days
Assessing the number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): pre dose and post dose
Area Under Curve (AUC) Time Frame
时间窗: 14 days
Assessing drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose
次要结局
- The plasma aldosterone, serum potassium and urine albumin levels(14 days)
- The effect of food on Area Under Curve (AUC) Time Frame(14 days)