NL-OMON49587已完成不适用
An open-label, single-sequence cross-over drug-drug interaction study to evaluate the effect of single and multiple oral doses of PHA-022121 on the pharmacokinetics of selective CYP1A2, CYP2C19, and CYP3A4 substrates in healthy subjects - DDI of PHA-022121 on PK of CYP1A2, CYP2C19 and CYP3A4.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
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 must be a healthy male or female subject, between 18 to 65 years of
- •age, extremes included, at screening.
- •2. Subject must have a body mass index (BMI; weight in kg divided by the square
- •in meters) between 18.0 and 30.0 kg/m2, extremes included, and a body weight
- •not less than 50.0 kg, inclusive, at screening.
- •3. Subject must sign an ICF indicating that he or she understands the purpose
- •of the study including the procedures required, and is willing to participate
- •in the study, including that he /she agrees to provide DNA samples for
- •research, before starting of any screening activities.
- •4. During the study and for a minimum of 1 spermatogenesis cycle (defined as
- •approximately 90 days) after receiving the last dose of study drug, a male
- •- who is sexually active with a woman of child-bearing potential and has not
- •had a vasectomy, must agree to use a barrier method of contraception (eg,
- •condom or partner with occlusive cap [diaphragm or cervical/vault caps]). In
- •addition, their female partner should also use a highly effective method of
- •birth control (eg, hormonal contraception , intra-uterine device) for at least
- •the same duration.
- •- Who is sexually active with a woman who is pregnant must use a condom.
- •- Must agree not to donate sperm until 90 days after receiving the last study
- •drug administration.
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 <90 mL/min at/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 National Cancer Institute (NCI) Common Terminology Criteria for
- •Adverse Events (CTCAE) version 4. 14, 2010 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 LLN ( reference of site applies for male and female,
- •respectively) lowering grad 1 or greater (<=6.5 mmol ; <=109 g/L );
- •- 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. Clinically significant abnormal values for hematology, clinical chemistry or
- •urinalysis at screening or at admission to the clinical site on Day -1 as
- •deemed appropriate by the investigator.
研究者
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