A Phase I, open-label, randomized, two-way crossover study to investigate the effects of morning versus evening repeated dosing on the pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in healthy female subjects. - Study to investigate the combination of GLPG3067,GLPG2222 and GLPG2737

Galapagos N.V.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Female subject between 18-70 years of age, inclusive, on the date of signing the informed consent form (ICF).
•- Being of non-childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition, a determination of follicle stimulating hormone (FSH) must be performed with FSH >35 mIU/mL to further confirm postmenopausal status without menstruation for >12 months. Subjects must have a negative serum pregnancy test. For surgical sterilization, documented confirmation will be requested.
•- Having a body mass index (BMI) between 18-30 kg/m2, inclusive.
•- Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead triplicate ECG, and clinical safety laboratory tests prior to the initial study drug administration. Clinical safety laboratory test results must be within the laboratory reference ranges for women, or test results that are outside the reference ranges for women need to be considered non-clinically significant in the opinion of the investigator.;Reference is made to the protocol for a complete overview of the inclusion criteria.

•- Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
•- Creatinine clearance <=80 mL/min using the Cockcroft-Gault formula for subjects aged <=50 years, or creatinine clearance <=70 mL/min using the Cockcroft-Gault formula for subjects aged >50 years. A 24-hour urine collection to determine the actual value may be performed to confirm creatinine clearance if required.
•- Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months or 5 times the half-life of the drug (whichever is longer) before the initial study drug administration.
•- Participation in a drug, drug and device delivery system or combination, or biological investigational research study within 8 weeks or 5 times the half-life of the investigational drug, if the half-life is known (whichever is longer) prior to initial study drug administration. ;Reference is made to the protocol for a complete overview of the exclusion criteria.

发起方

Galapagos N.V.