Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The number of subjects with abnormal electrocardiogram
研究概览
简要总结
The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.
Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
- •Subjects must have a body mass index between 18-28 kg/m² (included)
- •Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
排除标准
- •A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
- •Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study
- •A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
- •Subject expresses current desire to have (more) children
- •Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding
研究组 & 干预措施
GLPG0634 in Japanese subjects
Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days
干预措施: GLPG0634 50 mg (Drug)
GLPG0634 in Japanese subjects
Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days
干预措施: GLPG0634 100 mg (Drug)
GLPG0634 in Japanese subjects
Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days
干预措施: GLPG0634 200 mg (Drug)
Placebo in Japanese healthy subjects
Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days
干预措施: Placebo (Drug)
GLPG0634 in Caucasian subjects
In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days
干预措施: GLPG0634 200 mg (Drug)
Placebo in Caucasian healthy subjects
In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
The number of subjects with abnormal electrocardiogram
时间窗: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram
The amount of GLPG0634 and metabolite in plasma and urine
时间窗: Between Day 1 before dosing and Day 13 (72 hours after last dose)
To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested Safety Issue?: No
The number of subjects with abnormal laboratory parameters
时间窗: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters
The number of subjects with adverse events
时间窗: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs)
The number of subjects with abnormal vital signs
时间窗: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs
The number of subjects with abnormal physical examination
时间窗: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination
次要结局
- The amount of GLPG0634 mechanism-of-action-related biomarkers in blood(Between Day 1 before dosing and Day 11 (24 hours after last dose))