A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Intravenous Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Vss
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2 and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult males and females 18 to 45 or 65 to 85 years of age, inclusive.
- •Body mass index (BMI)between 18 to 36 kg/m2, inclusive.
- •Average frequency of ≥ 3 bowel movements per week.
排除标准
- •Persistent symptoms of functional GI disorder (such as irritable bowel syndrome, functional constipation, functional dyspepsia, or other symptom-based GI disorders unexplained by a pathologically based disorder) during the 6 months prior to screening, including a history of major surgery of the GI tract, excluding cholecystectomy and appendectomy.
- •History or presence of clinically significant respiratory, GI, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if the condition is well controlled and not anticipated to interfere with the objectives of the study.
研究组 & 干预措施
TD-8954 Dose 2
干预措施: TD-8954 (Drug)
TD-8954 Dose 1
干预措施: TD-8954 (Drug)
Placebo
干预措施: Placebo - saline (Drug)
结局指标
主要结局
Vss
时间窗: Day 5
Apparent volume of distribution at steady state
Cmax
时间窗: Day 5
Maximum plasma concentration
Tmax
时间窗: Day 5
Time to reach maximum plasma concentration.
t½
时间窗: Day 5
Time to 50% plasma concentration
AUC0-24
时间窗: Day 5
Area under the plasma concentration time curve 24 hours following the last dose.
AUC0-∞
时间窗: Day 5
Area under the plasma concentration time curve from 0 to infinity.
AUCtau
时间窗: Day 5
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
CLss
时间窗: Day 5
Apparent clearance
Plasma CL
时间窗: Day 1
Plasma clearance
Plasma Vz
时间窗: Day 1
Volume of distribution
次要结局
- Number of Subjects With Adverse Events(1 week)