A study of ASP0367 in people with kidneys that do not work well and in healthy people, Trial ID 0367-CL-1111

试验摘要

This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different groups of people.

本研究分为 2 个部分。Part 2 will only happen if the results between the 2 groups are different in Part 1. In each part, people in the study will stay in a research unit for 6 days and 5 nights. Later, they will return to the research unit for 1 check-up.

In Part 1, people whose kidneys work normally and people whose kidneys work very poorly (severe renal impairment) can take part.

If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work well (mild or moderate renal impairment) can take part.

In both parts of the study, people who can take part will be admitted to the research unit. The next day they will take tablets of ASP0367 just once. People will give blood and urine samples at various times during their stay. They will have their vital signs (heart rate and blood pressure) checked regularly. People will also have ECGs to check their heart rhythm. They will be asked if they have any medical problems. After 6 days, provided all the checks have been done and there are no medical problems, people in the study will leave the research unit.

People will return to the research unit for 1 check-up. This will be between 9 and 11 days after their last blood sample was taken during their previous stay in the unit. The check-up will include a physical exam, a check of people’s vital signs (heart rate and blood pressure), and blood tests. Also, people will have an ECG and be asked if they have had any medical problems.

获取更多信息

关于正在招募参与者的 A study of ASP0367 in people with kidneys that do not work well and in healthy people，您是否想了解更多临床试验中心相关信息？请在右侧填写您的信息联系我们，我们将予以回复。

地点

联系我们

正在招募

Advanced Pharma CR, LLC

迈阿密, 佛罗里达州, 美国, 33147

联系我们

正在招募

Nucleus Network

St Paul, 明尼苏达州, 美国, 55114

联系我们

正在招募

Inland Empire

Rialto, 加利福尼亚州, 美国, 92377

联系我们

试验信息

关注试验

参与者年龄

18 - 75 Years

疾病

弗里德赖希共济失调

心肌病

参与者性别

女性和男性

试验开展时间

2021年12月 - 2022年11月

分享给

更多研究详情

入选标准

Participant has a body mass index range of 18.5 to 40.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
女性受试者未怀孕且至少满足以下一个条件：
- Not a woman of child-bearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after Investigational Product (IP) administration.
Female participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after IP administration.
Female participant must not donate ova starting at first dose of IP and throughout the study period and for 28 days after IP administration.
Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 28 days after IP administration.
Male participant must not donate sperm during the treatment period and for 28 days after IP 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 28 days after IP administration.
受试者同意在参与本研究时不参与另一项干预性研究。
Participant has normal renal function as defined by estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease formula ≥ 90 mL/min per 1.73 m^2 or participant has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and by eGFR:
- 60 to < 90 mL/min per 1.73 m^2 for participants with mild renal impairment
- 30 to < 60 mL/min per 1.73 m^2 for participants with moderate renal impairment
- < 30 mL/min per 1.73 m^2 and not on hemodialysis, with approximately 50 percent of participants to have eGFR ≤ 20 mL/min per 1.73 m^2 for participants with severe renal impairment
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 day -1.
Participant has any condition, which makes the participant unsuitable for study participation.
Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
Participant has had previous exposure with ASP0367.
Participant has used moderate or strong inducers of Cytochrome P450 (CYP) 3A within the 3 months prior to day -1.
Participant has used a strong CYP3A inhibitor within 5 half lives, prior to day -1.
Participant has used proton pump inhibitor within the 2 weeks prior to IP administration.
Participant has used histamine 2 blockers within 24 hours prior to IP administration.
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 IP 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 any of the liver function tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and total bilirubin ≥ 1.5 × upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
Participant is an employee of Astellas, the study related contract research organization (CRO) or the clinical unit.
Participant has a positive result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test at screening.
Participant has consumed grapefruit, Seville oranges, grapefruit containing products or Seville orange containing products within 72 hours 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 used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on day -1, unless the positive result is due to an approved prescription medication (for participants with renal impairment only).
For US sites: Participant has a history of consuming > 14 units for male participants or > 7 units for female participants of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
For EU sites: Participant has a history of consuming > 21 units for male participants or > 14 units for female participants of alcohol per week within 3 months prior to day -1 (note: 1 unit = 10 g pure alcohol, 250 mL of beer [5 percent], 35 mL of spirits [35 percent] or 100 mL of wine [12 percent]) or the participant tests positive for alcohol at screening or on day -1.
Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 2 weeks prior to IP administration or will have a COVID-19 vaccine dose before the end-of-study visit (ESV).
Participant has a positive serology test for hepatitis A virus antibodies (immunoglobulin M), hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.

Participant with renal impairment will be excluded from participation in the study if any of the following apply:

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.
Participant has a mean pulse < 40 or > 90 bpm; mean systolic blood pressure (SBP) < 90 or > 160 mmHg; mean diastolic blood pressure (DBP) < 50 or > 100 mmHg (measurements taken in triplicate after participant has been resting in a supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
Participant has a mean QT interval using Fridericia’s correction (QTcF) of > 450 msec (for male participants) and > 480 msec (for female participants) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate may be taken.
Participant who has had a change in dose regimen of medically required medication(s) in the 2 weeks prior to screening (permitted concomitant medications) and/or participant for whom dose changes are likely to occur during the study (minor dose changes are allowed in agreement with the sponsor) and/or participant has used nonpermitted concomitant medication(s) in the 3 weeks prior to admission to the clinical unit.
Participant who has a renal disease secondary to malignancy.
Participant who has a fluctuating or rapidly deteriorating renal function within 4 weeks prior to IP administration, as indicated by strongly varying or worsening of clinical and/or laboratory signs of renal impairment within the screening period.
Participant has a hemoglobin result of < 9 g/dL.
Participant has a functioning kidney transplant.
Participant has cardiac troponin I for a given manufacturer’s assay being used that is above the historical upper range or participants with chronic kidney injury (and also without evidence of acute myocardial infarction) at screening.

Healthy participants with normal renal function will be excluded from participation in the study if any of the following apply:

Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
Participant has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol defined clinical laboratory tests at screening or on day -1.
Participant has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
Participant has a mean QTcF of > 430 msec (for male participants) and > 450 msec (for female participants) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John’s Wort) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day), topical dermatological products (including corticosteroid products), hormonal contraceptives and hormone replacement therapy.
Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
Participant has cardiac troponin (cTnI) > Upper limit of normal (ULN) (or cardiac troponin T [cTnT] > ULN if cTnI is not available) at screening.

常见问题

临床试验是否只针对晚期癌症患者？

虽然某些临床试验可能侧重于更晚期的癌症，但许多试验对处于不同癌症阶段的患者开放。每项研究都有关于参与资格的规定。例如，只有特定年龄段的患者或患有特定类型肿瘤的患者才能参与。

我是否需要停止当前治疗才能参加临床试验？

有时，研究人员希望参与者在临床试验期间继续接受当前治疗。有时，您可能需要暂停当前的治疗。如果研究性治疗无效，您通常可以恢复原有的治疗方案。

我是否应该担心会服用安慰剂？

在癌症临床试验中，只有当该类癌症尚无其他治疗方法时，才会使用安慰剂。这有助于将研究性治疗与安慰剂进行比较。安慰剂在癌症试验中很少使用，因为通常会采用最佳可用疗法，即所谓的“标准治疗方案”。

我是否需要医生转诊才能参加一项研究？

您的医生可能并不了解所有可供您参与的临床试验机会。请与您的医生或其他医疗服务提供者讨论您所找到的临床试验信息。他们可以帮助您判断临床试验是否适合您。If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

探索更多

A study of ASP0367 in people with kidneys that do not work well and in healthy people

试验摘要

更多研究详情

获取更多信息

地点

常见问题

探索更多

什么是临床试验?

为什么临床试验很重要？

为什么要参加临床试验