A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3121-modified Release Formulation in Adult, Healthy, Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 50
- 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 aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast.
The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (ULN). 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.
- •Subject must be able and willing to comply with restrictions on prior and concomitant medication.
- •Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
- •This list only contains the key inclusion criteria.
排除标准
- •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 was resolved at least 3 months prior to first dosing of the IP.
- •History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
- •Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.
- •Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate [eGFR] <=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •This list only contains the key exclusion criteria.
研究组 & 干预措施
GLPG3121 FE fed
Single dose of GLPG3121 in fed state
干预措施: GLPG3121 (Drug)
GLPG3121 SAD
Single doses of GLPG3121 at up to 3 dose levels in ascending order
干预措施: GLPG3121 (Drug)
Placebo SAD
Single doses of placebo
干预措施: Placebo (Drug)
GLPG3121 MAD
Multiple doses of GLPG3121 at up to 3 dose levels in ascending order
干预措施: GLPG3121 (Drug)
Placebo MAD
Multiple doses of placebo
干预措施: Placebo (Drug)
GLPG3121 FE fasted
Single dose of GLPG3121 in fasted state
干预措施: GLPG3121 (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 8 months
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo
次要结局
- Cmax of GLPG3121 in MAD(Between Day 1 pre-dose and Day 19)
- Area under the plasma concentration-time curve (AUC) of GLPG3121 in SAD(Between Day 1 pre-dose and Day 6)
- AUC of GLPG3121's main metabolite in MAD(Between Day 1 pre-dose and Day 19)
- AUC of GLPG3121 in MAD(Between Day 1 pre-dose and Day 19)
- Maximum observed plasma concentration (Cmax) of GLPG3121 in SAD(Between Day 1 pre-dose and Day 6)
- t1/2 of GLPG3121 in MAD(Between Day 1 pre-dose and Day 19)
- Cmax of GLPG3121's main metabolite in SAD(Between Day 1 pre-dose and Day 6)
- t1/2 of GLPG3121's main metabolite in SAD(Between Day 1 pre-dose and Day 6)
- t1/2 of GLPG3121's main metabolite in MAD(Between Day 1 pre-dose and Day 19)
- Cmax of GLPG3121's main metabolite in MAD(Between Day 1 pre-dose and Day 19)
- AUC of GLPG3121's main metabolite in SAD(Between Day 1 pre-dose and Day 6)
- Terminal elimination half-life (t1/2) of GLPG3121 in SAD(Between Day 1 pre-dose and Day 6)