A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Curve
研究概览
简要总结
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoker for at least 3 months
- •BMI within 18 to 30 kg/m2
- •Able to speak, read, and understand English or Spanish
排除标准
- •Clinically significant cardiac, pulmonary, hepatic or renal disease
- •History of substance abuse or alcohol dependence within past 2 years
- •Inability to fast for a minimum of 14 hours
- •Inability to swallow large capsules/tablets
- •Pending legal charges or is on probation
研究组 & 干预措施
Part 1: Single Ascending Dose
干预措施: Indoximod HCL (F2) tablets (Drug)
Part 1: Single Ascending Dose
干预措施: Placebo (Other)
Part 2: Bioavailability and Food Effect
- Single dose of Indoximod HCL (F2) formulation under fasting conditions
- Single dose of Indoximod HCL (F2) formulation under fed conditions
- Single dose of Indoximod base formulation under fasting conditions
干预措施: Indoximod base formulation (Drug)
Part 2: Bioavailability and Food Effect
- Single dose of Indoximod HCL (F2) formulation under fasting conditions
- Single dose of Indoximod HCL (F2) formulation under fed conditions
- Single dose of Indoximod base formulation under fasting conditions
干预措施: Indoximod HCL (F2) tablets (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve
时间窗: up to 20 Days
Part 2
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
时间窗: up to 4 Days
Part 1
次要结局
- Percentage of patients with adverse events(up to 36 Days)