An Open Label Study to Compare the Oral Bioavailability of a Tablet of GLPG1690 Relative to a Capsule After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Tablet
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses
研究概览
简要总结
This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between 18-50 years of age, inclusive
- •Body mass index (BMI) between 18-30 kg/m2, inclusive, with a weight of at least 50 kg.
- •Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory findings.
- •Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration
- •Non-smokers and not using any nicotine-containing products.
- •Negative urine drug screen and alcohol breath test.
- •Current sexually active male agrees to use adequate contraception/preventive exposure measures from the time of first dose of study drug, during the study and until 12 weeks after the last study drug dose.
- •Subjects should be willing to consume the non-vegetarian high-fat and high-calorie breakfast.
- •Able and willing to sign the ICF
排除标准
- •Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- •Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
- •History of or a current immunosuppressive condition.
- •Presence of abnormal liver function. Diagnosis of disease of Gilbert is accepted. Retesting is allowed.
- •Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula. Retesting is allowed.
- •Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- •History of malignancy within the past 5 years
- •Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF >450 ms, or a known long QT syndrome).
- •Clinically relevant abnormalities detected on vital signs.
- •Dietary requirements precluding participation in the study
- •Significant blood loss (including blood donation [≥450 mL]), or transfusion of any blood product within 8 weeks prior to the signing of ICF.
- •Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
- •Consumption of large quantities of caffeinated coffee or tea (>6 cups/day), or equivalent.
- •Concurrent participation or participation in a drug or drug/device investigational research study.
- •Subjects who participated in a previous study with the same compound (GLPG1690).
- •Investigator or any sub-investigator, or other staff or relative.
- •Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
研究组 & 干预措施
Treatment B
GLPG1690 oral tablets after breakfast
干预措施: GLPG1690 (Drug)
Treatment C
GLPG1690 oral tablets after overnight fast
干预措施: GLPG1690 (Drug)
Treatment A
GLPG1690 oral capsules after breakfast
干预措施: GLPG1690 (Drug)
结局指标
主要结局
Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses
时间窗: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavialability of GLPG1690 by assessing PK parameters
Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses
时间窗: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavialability of GLPG1690 by assessing PK parameters
Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses
时间窗: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing
Determine the bioavailability of GLPG1690 by assessing PK parameters
次要结局
- The number of subjects with abnormal vital signs(Throughout the study from screening until the follow up visit (day 7 of dosing period 3))
- The number of subjects with abnormal laboratory analysis(Throughout the study from screening until the follow up visit (day 7 of dosing period 3))
- The number of subjects with adverse events(Throughout the study from screening until the follow up visit (day 7 of dosing period 3))
- The number of subjects with abnormal physical examination(Throughout the study from screening until the follow up visit (day 7 of dosing period 3))
- The number of subjects with abnormal ECG(Throughout the study from screening until the follow up visit (day 7 of dosing period 3))