NL-OMON44647已完成不适用
A Phase I, drug-drug interaction study between oral doses of GLPG1205 and an OCT2 probe substrate (metformin) or a BCRP probe substrate (rosuvastatin) in healthy male subjects - GLPG1205-CL-104 (CS0286)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject has signed the informed consent form prior to any study related activity.
- •2. Subject is a healthy male volunteer between 18 and 50 years of age (inclusive) at the time of informed consent signature.
- •3. Subject has a BMI equal to or higher than 18.0 kg/m2 and equal to or lower than 30.0 kglm2 at the screening
- •4. Subject is appropriate for the study in the judgment of the investigator, based on physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and subject's interview.
- •5. Subject has a high probability for compliance with and completion of the study.
- •6. Discontinuation of all medications (including over-the-counter medications, vitamin and herbal supplements) with the exception of occasional paracetamol (maximum dose of 2 g/day and maximum 10 g/2 weeks) at least 3 weeks, or 5 half-lives of the drug, whichever is longer, prior to the first study drug administration.
- •7. A non-smoker and not using any nicotine-containing products for at least 1 year prior to the study screening.
- •8. Negative tests for drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, and opiates), alcohol screen, and cotinine screen.
- •9. Subject agrees that he will use a condom and that in addition to that he (and his female partner of child-bearing potential) will use a highly effective method of contraception and will not donate sperm from the first study drug administration to 12 weeks after the last study drug administration.
排除标准
- •1. Subject shows clinically significant abnormalities in Screening, Day -1 or Day 1 physical examination, ECG or vital signs, according to the investigator*s judgment.
- •2. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- •3. History of malignancy in the last 5 years, except basal cell carcinoma of the skin that has been treated and with no evidence of recurrence.
- •4. Subject has been exposed to GLPG1205 before.
- •5. Known hypersensitivity to GLPG1205 or excipients of the formulation, metformin, biguanides or rosuvastatin. A history of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization.
- •6. Having a contraindication as indicated in the respective Summary of Product Characteristics (or Package Leaflets) for metformin or rosuvastatin.
- •7. Subject is of Asian origin.
- •8. Subject had major surgery, donated or lost 1 unit of blood or plasma (approximately 500 mL) within 6 weeks prior to the first intake of the study drug.
- •9. Subject has participated in another investigational trial within 90 days prior to the first intake of the study drug in this study.
- •10. Subject has used any type of medication (including herbal medicine and vitamin supplements) within 3 weeks prior to the first intake of the study drug.
- •11. Clinically significant illness in the 12 weeks prior to study dosing, including severe vomiting or diarrhoea.
- •12. Presence or having sequelae of GI, liver or kidney (creatinine clearance * 90 mL/min using the Cockcroft formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •13. Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
- •14. Any history of vitamin B12 deficiency.
- •15. Clinically significant abnormalities detected on laboratory safety testing during Screening or Day -1, including (but not limited to):
- •a. Hemoglobin < 10 g/dL
- •b. WBC count < 3.0 x 10^9 cells/L
- •c. Neutrophil count < 1.5 x 10^9 cells/L
- •d. Platelet count < 100 x 10^9 cells/L
- •e. Serum ALT or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN)
- •f. Total bilirubin level > 1.5 x ULN, except in the case of documented Gilbert*s syndrome
- •16. Subject has a positive urinary drug screen during Screening or Day -1 (incl. amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamine, morphine, phencyclidine, and tricyclic antidepressants).
- •17. History of abuse of alcohol or drugs in the last 2 years (alcohol >23 units/week).
- •18. Subject has a positive test for HIV antibody, HBsAg, or HCV antibody.
- •19. Subject has a positive alcohol test during Screening or Day -1.
- •20. Subject consumes more than 5 cups of caffeine containing beverages per day.
- •21. Clinically significant abnormalities, during Screening or Day -1 on ECG of rhythm or conduction (e.g., QTcF > 450 ms, known long-QT syndrome), excluding first degree heart block.
- •22. Subject plans to father a child during the course of the study.
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