A Phase I, open-label, randomized, single-dose, two-way crossover study to compare the relative bioavailability of GLPG2737 given as a capsule formulation and an oral suspension - Pharmacokinetics of GLPG2737 given as a capsule and an oral suspension

Galapagos NV0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•- Male between 18-50 years of age, inclusive, on the date of signing the Informed Consent Form (ICF).
•- 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 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 males or test results that are outside the reference ranges for males need to be considered non clinically significant in the opinion of the investigator. One retest is allowed if deemed appropriate by the investigator without asking permission from the sponsor.
•- Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) least 2 weeks prior to the first study drug administration.;Reference is made to the protocol for a complete overview of the inclusion criteria.

•* History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection type 1 and 2).
•* Clinically significant illness in the 3 months before screening.
•* Presence or having sequelae of gastrointestinal, liver, kidney (creatinine clearance [CLCR] * 80 mL/min using the Cockcroft-Gault formula: if calculated result * 80 mL/min, a 24 hour urine collection to determine actual value can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
•* Treatment with any drug known to have a well-defined potential for toxicity to a major organ within the last 3 months or 5-half-lives of the drug (whichever is longer) before the initial drug administration.
•* Participation in a drug, drug and device delivery system or combination or biologic 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 screening.;Reference is made to the protocol for a complete overview of the exclusion criteria.

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