A Phase 1, non-randomized, fixed sequence, open-label, drug-drug interaction study to evaluate the effect of GLPG3970 on the pharmacokinetics of methotrexate and sulfasalazine in adult, healthy subjects - GLPG3970 DDI study with methotrexate and sulfasalazine

Galapagos NV0 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Male or female Caucasian between 18-55 years of age (extremes included), on
•the date of signing the informed consent form (ICF).
•2. Females should be of non-childbearing potential defined as permanently
•surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries,
•bilateral salpingectomy or hysterectomy, i.e. surgical removal of uterus), or
•with no menses for 12 or more months without an alternative medical cause AND a
•follicle-stimulating hormone (FSH) level >35 IU/L. These subjects must also
•have a negative pregnancy test. For surgical sterilization, documented
•confirmation will be requested.
•3. A body mass index (BMI) between 18-30 kg/m2, inclusive.
•4. A BCRP c421C/C genotype.
•5. 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 non investigational medicinal product (NIMP) 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.

•1. Known hypersensitivity to the IMP (GLPG3970), or NIMPs (MTX and
•sulfasalazine), or sulfa drugs, or to their ingredients, or history of a
•significant allergic reaction to IMP or NIMPs ingredients as determined by the
•investigator.
•2. 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
•3. History of or a current immunosuppressive condition (e.g. human
•immunodeficiency virus [HIV]
•infection).
•4. Having any illness, judged by the investigator as clinically significant, in
•the 3 months prior to first
•dosing of the NIMP.
•5. 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 can be done) or other conditions known to interfere with the
•absorption, distribution, metabolism, or excretion of drugs.
•6. Subjects with a N-acetyltransferase (NAT) 2 slow acetylator genotype (only
•applicable to Group 2
•receiving sulfasalazine).

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