A Randomised, Double-blind, Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curves (AUC) of lucerastat after single ascending doses of lucerastat
研究概览
简要总结
The objectives of this study were to evaluate the safety and tolerability of lucerastat, and to determine its pharmacokinetic profile as single oral doses at different strengths.
详细描述
The subjects were enrolled sequentially to five dose groups, starting with the lowest dose level. Subjects could participate in only one Group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 form.
- •Male subjects aged from 18 to 45 years at screening.
- •Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
- •Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
排除标准
- •History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
- •Serious adverse reaction or hypersensitivity to any drug.
- •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
Single ascending doses of lucerastat
Subjects were enrolled sequentially in 4 groups and received a single oral dose of lucerastat from 100 mg to 1000 mg in the morning of Day 1
干预措施: Lucerastat (Drug)
B.i.d. Dose Group
Subjects received two doses of lucerastat (2 x 1 g) 12 hours apart on Day 1
干预措施: Lucerastat (Drug)
Placebo for singe ascending doses
These subjects received matching placebo administered orally in the morning of Day 1
干预措施: Placebo (Drug)
Placebo for b.i.d.Group
These subjects received matching placebo administered orally in the morning and in the evening of Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the plasma concentration-time curves (AUC) of lucerastat after single ascending doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
AUC was calculated from time zero to time t (last PK blood sample in which drug was detected) and extrapolated to infinity for subjects receiving a single dose.
Number of participants with Adverse Events (AEs)
时间窗: From baseline up to 7 days post-administration
An AE was defined as any untoward medical occurrence in a clinical investigation subject, which did not necessarily have a causal relationship with the treatment.
Maximum plasma concentration (Cmax) of lucerastat after single ascending doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving a single dose.
Maximum plasma concentration (Cmax) of lucerastat after two daily doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
Cmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.
Time to reach Cmax (tmax) of lucerastat after single ascending doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving a single dose.
Time to reach Cmax (tmax) of lucerastat after two daily doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
tmax was determined directly from the observed plasma concentration-time curves of lucerastat in subjects receiving lucerastat twice daily.
Area under the plasma concentration-time curves (AUC) of lucerastat after two daily doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
AUC was calculated from time zero to time t (last PK blood sample in which drug was detected) and extrapolated to infinity for subjects receiving lucerastat twice daily
Terminal elimination half-life (t1/2) of lucerastat after single ascending doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 24 hours post administration
t1/2 was calculated from the corresponding plasma concentrations-time curves for subjects receiving a single dose
Terminal elimination half-life (t1/2) of lucerastat after two daily doses of lucerastat
时间窗: PK Blood samples were collected at pre-dose and at scheduled time points up to 48 hours after the first administration
t1/2 was calculated from the plasma concentrations-time curves for subjects receiving lucerastat twice daily
次要结局
- Change from baseline in heart rate(Up to 24 hours post administration)
- Change from baseline in blood pressure(Up to 24 hours post administration)
- Change from baseline in electrocardiogram (ECG) variables(Up to 24 hours post administration)
- Change from baseline in laboratory tests(Up to 24 hours post administration)