A Phase 1, Double-Blind, Randomized, Crossover Study in Older Healthy Subjects to Compare the Safety, Tolerability, and Pharmacokinetics of Lyt-100 (Deupirfenidone) to Pirfenidone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- Part 1: Cmax of BID deupirfenidone versus TID pirfenidone
研究概览
简要总结
A three-part, randomized, double-blind study in healthy older adults to identify a dose of deupirfenidone for further clinical study.
详细描述
A Phase 1 study to evaluate safety, tolerability, and PK in older healthy subjects of multiple twice daily (BID) or 3 times daily (TID) doses of deupirfenidone administered over 3 days compared to that of pirfenidone or placebo administered TID. The study also investigated the PK profile of deupirfenidone at steady state compared to that of pirfenidone at steady state and the effect of food on the PK profile of deupirfenidone and pirfenidone. The study was conducted in 3 parts. Part 1 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the tolerability differentiation of BID dosing of deupirfenidone to pirfenidone. Part 2 was a randomized, double-blinded, two-period crossover study conducted in healthy older adults to evaluate the tolerability differentiation of TID dosing of deupirfenidone to pirfenidone. Part 3 was a randomized, double-blinded, parallel arm, placebo-controlled study conducted in healthy older adults to evaluate the safety and tolerability of two doses of deupirfenidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Over-encapsulation of study drug
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 60 and 80 years old (inclusive) at the time of Screening.
- •In good general health at Screening, free from clinically significant laboratory values, or clinically significant unstable medical, surgical, or psychiatric illness, as determined by the Investigator. Subjects with mild, chronic, stable disease and on stable medication could be included if deemed medically prudent by the Investigator.
- •Has a body mass index (BMI) between ≥18.0 and ≤50.0 kg/m2 at Screening.
排除标准
- 未提供
研究组 & 干预措施
Part 3 Active
deupirfenidone 550/824 mg TID
干预措施: Deupirfenidone (Drug)
Part 3 Placebo
placebo TID
干预措施: Placebo (Drug)
Part 1 Active
deupirfenidone 850 mg BID
干预措施: Deupirfenidone (Drug)
Part 1 Active Comparator
pirfenidone 801 mg TID
干预措施: Pirfenidone (PFD) (Drug)
Part 2 Active
deupirfenidone 550 mg TID
干预措施: Deupirfenidone (Drug)
Part 2 Active Comparator
pirfenidone 801 mg TID
干预措施: Pirfenidone (PFD) (Drug)
结局指标
主要结局
Part 1: Cmax of BID deupirfenidone versus TID pirfenidone
时间窗: 14 days
To compare the Cmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design.
Part 2: Cmax of TID deupirfenidone versus TID pirfenidone
时间窗: 14 days
To compare the Cmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design.
Part 3: Cmax of TID deupirfenidone versus placebo
时间窗: 6 days
To evaluate the Cmax of two doses of deupirfenidone.
Part 1: AUC of BID deupirfenidone versus TID pirfenidone
时间窗: 14 Days
To compare the AUC of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design.
Part 1: Tmax of BID deupirfenidone versus TID pirfenidone
时间窗: 14 Days
To compare the Tmax of 850 mg BID dosing of deupirfenidone to 801 mg TID dosing of pirfenidone at steady state, in older healthy subjects, when administered in a two-period crossover design.
Part 2: AUC of TID deupirfenidone versus TID pirfenidone
时间窗: 14 Days
To compare the AUC of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design.
Part 2: Tmax of TID deupirfenidone versus TID pirfenidone
时间窗: 14 Days
To compare the Tmax of 550 mg TID deupirfenidone to 801 mg TID pirfenidone at steady state in older healthy subjects, when administered in a two-period crossover design.
Part 3: AUC of TID deupirfenidone versus placebo
时间窗: 6 Days
To evaluate the AUC of two doses of deupirfenidone.
Part 3: PK profile of TID deupirfenidone versus placebo
时间窗: 6 Days
To evaluate the Tmax of two doses of deupirfenidone.
次要结局
- Part 1: The effect of food on the Cmax of BID deupirfenidone versus TID pirfenidone(1 day)
- Part 2: The effect of food on the Cmax of TID deupirfenidone versus TID pirfenidone(1 day)
- Part 1: The effect of food on the AUC of BID deupirfenidone versus TID pirfenidone(6 Days)
- Part 1: The effect of food on the Tmax of BID deupirfenidone versus TID pirfenidone(1 Day)
- Part 2: The effect of food on the AUC of TID deupirfenidone versus TID pirfenidone(1 Day)
- Part 2: The effect of food on the Tmax of TID deupirfenidone versus TID pirfenidone(1 Day)