A First-in-human, Randomized, Double-blind, Placebo-controlled, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days 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
- 31
- 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
This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
- •Male between 18 to 55 years of age (extremes included), on the date of signing the ICF.
- •A Body Mass Index (BMI) between 18.0 to 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, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x the upper limit of normal range (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 nonclinically significant in the opinion of the investigator.
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.
- •Known contraindication or hypersensitivity to interferon-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part).
- •Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
- •Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
研究组 & 干预措施
GLPG3121 SAD
Single doses of GLPG3121 at up to 6 dose levels in ascending order
干预措施: GLPG3121 SAD (Drug)
Placebo SAD
Single doses of placebo
干预措施: Placebo SAD (Drug)
GLPG3121 MAD
Multiple doses of GLPG3121 at up to 4 dose levels in ascending order
干预措施: GLPG3121 MAD (Drug)
Placebo MAD
Multiple doses of placebo
干预措施: Placebo MAD (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 6 months.
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.
次要结局
- Terminal elimination half-life (t1/2) of GLPG3121 (h)(Between Day 1 pre-dose and Day 16)
- Area under curve (AUC) of GLPG3121 (μg.h/mL)(Between Day 1 pre-dose and Day 16)
- Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL)(Between Day 1 pre-dose and Day 16)