First-in-Human Single and Multiple Dose of GLPG1205
Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.
Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Antwerp、比利时
- SGS LSS Clinical Pharmacology Unit Antwerp
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:GLPG1205 single dose
Single oral dose of GLPG1205 suspension - ascending doses
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Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg
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安慰剂比较:安慰剂单剂量
单次口服安慰剂混悬剂
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Single dose, oral suspension matching placebo
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实验性的:GLPG1205 multiple doses
Multiple oral doses of GLPG1205 suspension - ascending doses
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Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg
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安慰剂比较:安慰剂多剂量
多次口服安慰剂混悬剂
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多剂量,每日一次,连续 14 天,口服混悬剂匹配安慰剂
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety and tolerability after single dose
大体时间:Between screening and 7-10 days after the last dose
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To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
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Between screening and 7-10 days after the last dose
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Safety and tolerability after multiple doses
大体时间:Between screening and 7-10 days after the last dose
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To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
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Between screening and 7-10 days after the last dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The amount of GLPG1205 in plasma and urine over time after a single oral dose
大体时间:Between Day 1 predose and 48 hours post dose
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To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects
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Between Day 1 predose and 48 hours post dose
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The amount of GLPG1205 in plasma and urine over time after multiple oral doses
大体时间:Between Day 1 predose and Day 16 (48 hours after the last dose)
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To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects
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Between Day 1 predose and Day 16 (48 hours after the last dose)
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Ratio of 6-b-hydroxycortisol/cortisol in urine
大体时间:Twelve hours before dosing on Day 1 and Day 14
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To assess the potential of CYP3A4 induction after repeated dosing with GLPG1205 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
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Twelve hours before dosing on Day 1 and Day 14
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Receptor occupancy by GLPG1205 on blood cells after a single dose
大体时间:Day 1 predose up to 24 hours post dose
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To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after a single oral dose in healthy subjects
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Day 1 predose up to 24 hours post dose
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Receptor occupancy by GLPG1205 on blood cells after multiple doses
大体时间:Day 1 and Day 14, predose up to 24 hours post dose
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To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after multiple oral doses in healthy subjects
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Day 1 and Day 14, predose up to 24 hours post dose
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- GLPG1205-CL-101
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