A Phase 1, Fixed Sequence, Open-label, Drug-drug Interaction Study to Evaluate the Effect of GLPG3970 on the Pharmacokinetics of Sulfasalazine in Adult, Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of sulfasalazine
研究概览
简要总结
GLPG3970 will be given with sulfasalazine to investigate the effect of co-administration on the pharmacokinetics of sulfasalazine, and on the safety and tolerability of the drugs in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Females should be of non-childbearing potential.
- •A body mass index (BMI) between 18.0 to 30.0 kg/m2, inclusive.
- •A breast cancer resistance protein (BCRP) c421C/C genotype.
- •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 the first sulfasalazine administration. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x 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 not clinically significant in the opinion of the investigator.
- •This list only contains the key inclusion criteria.
排除标准
- •Known hypersensitivity to the investigational product (IP) (GLPG3970), or sulfasalazine, or sulfa drugs, or to their ingredients, or history of a significant allergic reaction to IP or sulfasalazine 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 sulfasalazine.
- •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 sulfasalazine.
- •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.
- •Subjects with an N-acetyltransferase 2 (NAT2) slow acetylator genotype.
- •This list only contains the key exclusion criteria.
研究组 & 干预措施
Sulfasalazine + GLPG3970
干预措施: Sulfasalazine (Drug)
Sulfasalazine + GLPG3970
干预措施: GLPG3970 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) of sulfasalazine
时间窗: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Cmax of sulfapyridine
时间窗: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of sulfasalazine
时间窗: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
AUC0-inf of sulfapyridine
时间窗: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
Sulfapyridine to sulfasalazine AUC ratio
时间窗: Between Day 1 pre-dose and Day 12
To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of sulfasalazine and its active metabolite sulfapyridine in healthy subjects.
次要结局
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity(From Day 1 through study completion, an average of 1 month)
- Maximum observed concentration (Cmax) of GLPG3970(Between Day 5 pre-dose and Day 10)
- Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration (AUC0-t)(Between Day 5 pre-dose and Day 10)