JPRN-jRCT2071220072进行中（未招募）1 期
A Phase I, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of LY3526318, and to Investigate the Effect of LY3526318 on Metformin and Simvastatin Pharmacokinetics in Healthy Male Japanese Participants - J2D-JE-CVAD
Wakayama Naohiko0 个研究点目标入组 34 人开始时间: 2022年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
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
- >= 18age old 至 <= 55age old（—）
- 性别
- Male
入选标准
- •Male Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- •-Body weight of at least 50 kilogram (kg) and body mass index within the range 18 to 30 kilogram per square meter (kg/m2).
- •-Male participants must adhere to the contraceptive requirements.
- •-Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged not clinically significant by the investigator.
排除标准
- •-Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
- •-Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
- •-Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions.
- •-Show evidence of human immunodeficiency virus and/or positive human immunodeficiency virus antigens and/or antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
- •-Show evidence of syphilis or have a positive syphilis test.
- •Have an abnormal blood pressure (supine) as determined by the investigator.
- •-Are unwilling to stop herbal supplements, over-the-counter, or prescription medicines, including drugs that are known inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), within 14 days prior to study intervention administration and for the duration of the study. An exception is for acetaminophen at doses of less than or equal to (<=3) grams/day.
- •-Participated (defined as last dose of study drug) within 30 days prior to dosing in a clinical trial involving an investigational product or nonapproved use of a drug with a short half-life, or within 5 half-lives of an investigational product with a half-life longer than 6 days.
- •-Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission.
- •-Are unwilling to comply with the required dietary restrictions.
- •Additional Exclusion Criteria of Part C:
- •-Have known allergies to iohexol, iodine, simvastatin, metformin, and related compounds or any components of the formulation.
- •-Show evidence of CYP3A5 *1 allele (CYP3A5*1/*1 or CYP3A5*1/*3).
- •-Confirmed creatinine clearance <90 milliliter per minute (mL/min) at the screening period assessment.
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