NCT02903095已完成1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects
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
- 66
- 试验地点
- 1
- 主要终点
- Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
研究概览
简要总结
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
- •Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
- •Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
- •Males must abstain from sex or use highly effective methods of birth control
- •Negative for HIV, and Hepatitis A, B, and C
排除标准
- •Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
- •Subjects with a history of angioedema.
- •Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- •Subject has acute illness (gastrointestinal, infection [e.g., influenza] or known inflammatory process)
- •Subject bradycardia
- •Subject has hypertension
- •Subjects has orthostatic hypotension
- •Subjects has orthostatic tachycardia
- •Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
- •Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
- •Additional exclusion criteria apply
研究组 & 干预措施
TD-1439
Experimental
Capsule formulation
干预措施: TD-1439 (Drug)
Placebo
Placebo Comparator
Capsule formulation
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
时间窗: From Day 1 through end of study (Day 10)
次要结局
- PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)(Day 1 through Day 10)
- PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)(Day 1 through Day 10)
- PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)(Day 1 through Day 10)
- PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)(Day 1 through Day 10)
- PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)(Day 1 through Day 10)
- PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)(Day 1 through Day 10)
- Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 4))
- Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 4))
- Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)(Day 1 through Day 10)
- PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)(Day 1 through Day 10)
- Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 4))
- PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)(Day 1 through Day 10)
- PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)(Day 1 through Day 10)
- PK of TD-1439 in urine after multiple doses - Clr (renal clearance)(Day 1 through Day 10)
- Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 4))
研究者
研究点 (1)
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