A Single-center, Open-label Study to Investigate the Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cmax of lucerastat
研究概览
简要总结
A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the concomitant administration of the two treatments will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in the local language prior to any study-mandated procedure.
- •Body mass index from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- •Normal renal function confirmed by creatinine clearance ≥ 80 mL/min using Cockroft-Gault formula at Screening.
排除标准
- •Known hypersensitivity to cimetidine, lucerastat, or drugs of the same class, or any of their excipients.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
研究组 & 干预措施
Treatment period A & B
Treatment period A: Subjects receive a single oral dose of 500 mg lucerastat on Day 1 under fasted conditions.
Treatment period B: From Day 3 to Day 9, subjects receive a b.i.d. (every 12 h) oral dose of 800 mg cimetidine under fasted conditions (Treatment period B1; from Day 3 to Day 5). On Day 6, subjects receive a single oral dose of 500 mg lucerastat concomitantly with the morning dose of 800 mg cimetidine under fasted conditions (Treatment period B2; from Day 6 to Day 10).
干预措施: Lucerastat (Drug)
Treatment period A & B
Treatment period A: Subjects receive a single oral dose of 500 mg lucerastat on Day 1 under fasted conditions.
Treatment period B: From Day 3 to Day 9, subjects receive a b.i.d. (every 12 h) oral dose of 800 mg cimetidine under fasted conditions (Treatment period B1; from Day 3 to Day 5). On Day 6, subjects receive a single oral dose of 500 mg lucerastat concomitantly with the morning dose of 800 mg cimetidine under fasted conditions (Treatment period B2; from Day 6 to Day 10).
干预措施: Cimetidine (Drug)
结局指标
主要结局
Cmax of lucerastat
时间窗: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
T1/2 of lucerastat
时间窗: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
AUC(0-t) of lucerastat
时间窗: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
AUC(0-inf) of lucerastat
时间窗: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
AUC(0-48) of lucerastat
时间窗: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Tmax of lucerastat
时间窗: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
次要结局
- Number of treatment-emergent SAEs(From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days))
- Number of treatment-emergent AEs(From Day 1 to End-of-Study (for up to 13 days))