NL-OMON55090已完成不适用
A first-in-human, randomized, double-blind, placebo-controlled, study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of GLPG4059 in adult, healthy, male subjects. - GLPG4059 single ascending dose study to investigate safety and PK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 57
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. Male between 18-54 years of age
- •2. A BMI) between 18.0-30.0 kg/m2, inclusive.
- •3. Judged to be in good health by the investigator based upon the results of a
- •medical history, physical examination, vital signs, 12-lead ECG, and fasting
- •clinical laboratory safety tests, available at screening and prior to
- •randomization. ECG and vital signs parameters must be within the normal ranges
- •as described in Appendix 1. Bilirubin, aspartate aminotransferase (AST), and
- •alanine aminotransferase (ALT) must be no greater than 1.5x ULN. Fasting plasma
- •glucose must be <6.99 mmol/L, fasting defined as no caloric intake for at least
- •8 hours and hemoglobin A1c (HbA1c) <6.5% (48 mmol/mol). The test should be
- •performed in a laboratory using a method that is national glycohemoglobin
- •standardization program (NGSP) certified and standardized to the diabetes
- •control and complications trial (DCCT) assay. 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.
- •4. Subject must be able and willing to comply with restrictions on prior
- •medication as described in Section 6.3.2.
- •5. Negative screen for drugs (amphetamines, barbiturates, benzodiazepines,
- •cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
- •6. Able and willing to comply with the protocol requirements and signing the
- •informed consent form (ICF) as approved by the Independent Ethics Committee
- •(IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
排除标准
- •1. Known hypersensitivity to IMP ingredients or history of a significant
- •allergic reaction to IMP 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
- •For the complete overview see the protocol.
研究者
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