NCT02047656终止1 期
A Two Part Study Including a Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LFF269 After b.i.d Dosing in Healthy Volunteers and an Open Label, Multiple Dose Pharmacokinetics Study in Hypertension Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)
研究概览
简要总结
This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive.
- •Patients with mild-to-moderate uncomplicated essential hypertension
排除标准
- •History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
- •A history of clinically significant ECG abnormalities.
- •Known history or current clinically significant arrhythmias.
- •History of hypertension, adrenal or endocrine disease.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- •Smokers (use of tobacco products in the previous 3 months).
- •History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •A positive Hepatitis B surface antigen or Hepatitis C test result.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential.
- •Known history or evidence of a secondary form of hypertension
- •Type 1 or type 2 diabetes mellitus.
- •History of heart diseases
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo to LFF269 (Part 1)
Placebo Comparator
Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers
干预措施: Placebo to LFF269 (Drug)
LFF269 (Part 1)
Experimental
LFF269 twice daily (b.i.d) for 10 days in healthy volunteers
干预措施: LFF269 (Drug)
LFF269 (Part 2)
Experimental
LFF269 twice daily (b.i.d) for 5 days in patients with hypertension
干预措施: LFF269 (Drug)
结局指标
主要结局
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)
时间窗: 10 days
次要结局
- Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension](Day 1)
- Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 1- Healthy volunteers](Day 10)
- Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers](Day 1)
- Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension](Day 1)
- Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 2 - Patients with hypertension](Day 5)
- Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)(5 days)
- Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers](Day 1)
- Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension](Up to Day 5)
- Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers](Up to Day 10)
研究者
研究点 (1)
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