NL-OMON53489已完成不适用
A phase I, open-label, randomized, two period, two-way cross over study to assess the influence of a high-calorie, high fat meal on the bioavailability of a 40 mg extended release PHA 022121 oral formulation - Food effect study on the bioavailability of PHA-022121 formulations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
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 64（—）
入选标准
- •1. Subject must sign an ICF indicating that the subject understands the purpose
- •of the study including the procedures required, potential risks involved, and
- •is willing to participate in the study before starting any screening activities.
- •2. Adult male or female subjects, between 18 to 65 years of age (inclusive) at
- •the time of informed consent.
- •3. Subject must have a body mass index (BMI) between 18.0 and 35.0 kg/m2
- •(inclusive), and a body weight not less than 50.0 kg, inclusive, at screening.
- •4. A subject may be enrolled if she/he is willing and able to adhere to the
- •contraceptive requirement.
- •5. All female subjects must have a negative serum β-human chorionic
- •gonadotropin (β-hCG) pregnancy test at Screening and at Day -1 of each
- •treatment period.
- •Further criteria apply
排除标准
- •1. Subject has a history of current clinically significant medical illness
- •including (but not limited to) cardiac arrhythmias or other cardiac disease,
- •hematologic disease, lipid abnormalities, significant pulmonary disease,
- •including bronchospastic respiratory disease, diabetes mellitus, hepatic or
- •renal insufficiency (estimated creatinine clearance < 62 mL/min/1.73m2 at
- •screening, calculated by MDRD formula), thyroid disease, neurologic or
- •psychiatric disease, infection, or any other illness, that in the
- •Investigator*s and/or Sponsor*s medical monitor opinion should exclude the
- •subject or that could interfere with the interpretation of the study results.
- •2. Subject has one of the following laboratory abnormalities at screening as
- •defined by the Common Terminology Criteria for Adverse Events (CTCAE) version
- •5.0, 27 November 2017 and in accordance with the normal ranges of the clinical
- •laboratory if no gradings are available.
- •- Serum creatinine elevation grade 1 or greater (>1.1 x upper limit of normal
- •range [ULN]);
- •- Hemoglobin below lower limit of normal range (LLN) (reference of site );
- •- Platelet count below LLN;
- •- Absolute neutrophil count lowering grade 1 or greater (<=1,5 109/L);
- •- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > ULN;
- •- Total bilirubin.> ULN;
- •- Any other toxicity grade 2 or above, except for grade 2 elevations for
- •triglycerides, low density lipoprotein (LDL) cholesterol and/or total
- •cholesterol.
- •3. Subject underwent surgery or has a medical condition that might
- •significantly affect absorption of medicines (e.g., stomach bypass,
- •cholecystectomy, etc.) as judged by the Investigator.
- •4. Subject has clinically significant abnormal values for hematology, clinical
- •chemistry or urinalysis at screening or at admission to the clinical site on
- •Day -1 as judged by the Investigator.
- •5. Subject, at screening, has a positive test for human immunodeficiency virus
- •(HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C
- •virus (HCV) antibodies.
- •Further criteria apply
研究者
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