JPRN-jRCT2031220304已完成1 期
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 in Participants with Renal Impairment Compared to Healthy Participants with Normal Renal Function
Gabriel P. Haas0 个研究点目标入组 28 人开始时间: 2022年8月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Participant has a BMI range of 17.6 to 30.0 kg/m^2 inclusive and weighs at least 50 kg for male participants and 40 kg for female participants at screening.
- •- Female participant is not pregnant and at least 1 of the following conditions apply:
- •o Not a woman of child-bearing potential (WOCBP)
- •o WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
- •- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after study intervention administration.
- •- Female participant must not donate ova starting at study intervention administration and throughout the study period and for 30 days after study intervention administration.
- •- Male participant with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 30 days after study intervention administration.
- •- Male participant must not donate sperm during the treatment period and for 30 days after study intervention administration.
- •- Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after study intervention administration.
- •- Participant agrees not to participate in another interventional study while participating in the present study.
- •- Participant has normal renal function or participant has varying degrees of chronic kidney disease (CKD) as defined by the National Kidney Foundation and calculated by individual estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula and individual body surface area (BSA):
- •o eGFR 60 to < 90 mL/min for participants with mild renal impairment
- •o eGFR 30 to < 60 mL/min for participants with moderate renal impairment
- •o eGFR < 30 mL/min without dialysis for participants with severe renal impairment, with approximately 50% of participants to have an eGFR of <= 20 mL/min.
- •o eGFR >= 90 mL/min for participants with normal renal function
- •- Participant has adequate venous access.
排除标准
- •- Participant has received any investigational therapy within 28 days or 5 half-lives whichever is longer, prior to screening.
- •- Participant has any condition which makes the participant unsuitable for study participation.
- •- Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
- •- Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- •- Participant has had previous exposure with ASP5354.
- •- Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) >= 1.5 x upper limit of normal [ULN] on day -1. In such a case, the assessment may be repeated once.
- •- Participant has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study intervention administration.
- •- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
- •- Participant has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1.
- •- Participant has a history of consuming > 16 units of alcohol per week within 3 months prior to day -1 (note: 1 unit = 10 grams pure alcohol, 250 ml of beer [5%], 35 milliliters [ml] of spirits [35%] or 100 ml of wine [12%]) or the participant tests positive for alcohol at screening or on day -1.
- •- Participant has body temperature < 35.0 degrees Celsius (C) or >= 37.5 degrees C on day -1.
- •- Participant has used any moderate or strong inducers of Cytochrome P450 family 3 subfamily A (CYP3A) in the 3 months prior to day -1.
- •- Participant has had significant blood loss, donated >= 400 ml of whole blood within 90 days, >= 200 ml of whole blood within 30 days or donated blood components within 14 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
- •- Participant has a positive serology test for hepatitis A virus (HAV) antibodies (immunoglobulin M [IgM]), hepatitis B core (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or antigen, antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 or syphilis at screening.
- •- Participant is an employee of Astellas, the study-related contract research organization (CRO) or the clinical unit.
- •- Participant has consumed grapefruit/Seville oranges or grapefruit/Seville orange-containing products within 72 hours prior to day -1.
- •- Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 2 weeks prior to study intervention administration or will have a COVID-19 vaccine dose before the end-of-study visit (ESV).
- •- Participant has a positive result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or on day -1.
- •Additional criteria for participants with renal impairment:
- •- Participant has a history of any clinically significant illness (other than renal disease and conditions related to the renal disease, such as stable diabetes and stable hypertension), medical condition or laboratory abnormality within 3 months prior to screening which preclude the participant from study p
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