A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects
2022年2月11日 更新者:Galapagos NV
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG3667 in Adult, Healthy Male Subjects
This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.
研究概览
研究类型
介入性
注册 (实际的)
23
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Gent、比利时、9000
- Drug Research Unit Ghent
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
This list only contains the key inclusion criteria.
Exclusion Criteria:
- Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that has resolved at least 3 months prior to first dosing of the IP.
This list only contains the key exclusion criteria.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:GLPG3667 SD
Participants will receive a single dose of GLPG3667
|
GLPG3667胶囊
|
安慰剂比较:Placebo SD
Participants will receive a single dose of matching placebo
|
匹配的安慰剂胶囊
|
实验性的:GLPG3667 MD
Participants will receive repeated doses of GLPG3667 for 13 days.
|
GLPG3667胶囊
|
安慰剂比较:Placebo MD
Participants will receive repeated doses of matching placebo for 13 days.
|
匹配的安慰剂胶囊
|
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 |
---|---|---|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
大体时间:From screening through study completion, an average of 3 months
|
To evaluate the safety and tolerability of single and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
|
From screening through study completion, an average of 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum observed plasma concentration (Cmax) of GLPG3667 - SD
大体时间:Between Day 1 pre-dose and Day 4
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 4
|
Maximum observed plasma concentration (Cmax) of GLPG3667 - MD
大体时间:Between Day 1 pre-dose and Day 16
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 16
|
Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD
大体时间:Between Day 1 pre-dose and Day 4
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 4
|
Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD
大体时间:Between Day 1 pre-dose and Day 16
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 16
|
Terminal elimination half-life (t1/2) of GLPG3667 - SD
大体时间:Between Day 1 pre-dose and Day 4
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 4
|
Terminal elimination half-life (t1/2) of GLPG3667 - MD
大体时间:Between Day 1 pre-dose and Day 16
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 16
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Natalia Rueda-Rincon, MD, PhD、Galapagos NV
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月20日
初级完成 (实际的)
2022年1月14日
研究完成 (实际的)
2022年1月14日
研究注册日期
首次提交
2021年7月19日
首先提交符合 QC 标准的
2021年7月19日
首次发布 (实际的)
2021年7月26日
研究记录更新
最后更新发布 (实际的)
2022年2月14日
上次提交的符合 QC 标准的更新
2022年2月11日
最后验证
2022年2月1日
更多信息
与本研究相关的术语
其他研究编号
- GLPG3667-CL-118
- 2021-002488-23 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的