A First-in-human, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of GLPG4059 in Adult, Healthy, Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Galapagos NV
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
研究概览
简要总结
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between 18-54 years of age (extremes included), on the date of signing the informed consent form (ICF).
- •A body mass index (BMI) between 18-30 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 ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. ECG and vital signs parameters must be within the normal ranges. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal (ULN). Fasting plasma glucose must be <6.99 mmol/L, fasting defined as no caloric intake for at least 8 hours and hemoglobin A1c (HbA1c) <6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is national glycohemoglobin standardization program (NGSP) certified and standardized to the diabetes control and complications trial (DCCT) assay. 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.
排除标准
- •Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP 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 was resolved at least 3 months prior to first dosing of the IMP.
- •This list only contains the key exclusion criteria.
研究组 & 干预措施
GLPG4059 SAD
Single doses of GLPG4059 at up to 6 dose levels in ascending order
干预措施: GLPG4059 oral suspension (Drug)
Placebo SAD
Single doses of placebo
干预措施: Placebo (Drug)
GLPG4059 rBA/FE oral suspension fasted
Single dose of GLPG4059 in fasted state
干预措施: GLPG4059 oral suspension (Drug)
GLPG4059 rBA/FE tablet fed
Single dose of GLPG4059 in fed state
干预措施: GLPG4059 tablet (Drug)
GLPG4059 rBA/FE tablet fasted
Single dose of GLPG4059 in fasted state
干预措施: GLPG4059 tablet (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
时间窗: From screening through study completion, an average of 7 months
To evaluate the safety and tolerability of single ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo.
次要结局
- Maximum observed plasma concentration (Cmax) of GLPG4059(Between Day 1 pre-dose and Day 4)
- Area under curve (AUC) of GLPG4059(Between Day 1 pre-dose and Day 4)
- Terminal elimination half-life (t1/2) of GLPG4059(Between Day 1 pre-dose and Day 4)