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正在招募
安斯泰来研究编号
0367-CL-1101

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

安斯泰来研究编号
0367-CL-1101
Clinicaltrials.gov 登记号
NCT04855201
EUCTIS ID
N/A
EudraCT 编号
N/A
jRCT ID
N/A
CN CDE ID
N/A
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试验摘要

The purpose of this study is to to evaluate the effect of ASP0367 on improvement of aerobic capacity relative to placebo, as well as evaluate the safety and tolerability of ASP0367 relative to placebo. This study will also evaluate the effect of ASP0367 on improvement of other aerobic capacity parameters relative to placebo, as well as evaluate the effect of ASP0367 on improvement of functional capacity relative to placebo.

更多研究详情

研究分期
1
研究产品
ASP0367
研究产品
  • ASP0367
  • 安慰剂
    • 研究类型
    Interventional
    盲法
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    入组人数
    40
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    关于正在招募参与者的 A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction，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。

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
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      正在招募
      Brigham and Women's Hospital
      Boston, MA, 美国, 02115
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      试验信息
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      参与者年龄
      18 - 60 years
      Diamond icon
      疾病
    • 肺/血液病
      • Gender icon
      参与者性别
      女性和男性
      Calendar icon
      试验开展时间
      May 2021 - Jul 2022
      更多研究详情
      入选标准
      • Participant agrees and is able to adhere to the study requirements for the length of the study, including undergoing both aCPET and SHAPE Test.
      • Participant has a body mass index (BMI) range of 18.5 to 30 kg/m^2, inclusive and weighs at least 50 kg at screening.
      • Participants with reduced maximum oxygen uptake due to poor SOE, defined as peak exercise ([Ca-VO2])/[Hb]) ≤ 0.85 and VO2max < 85% predicted in the absence of a cardiac or pulmonary mechanical limit, determined by aCPET within 6 months prior to day 1 or participants with reduced maximum oxygen uptake due to poor SOE, defined as peak exercise ([Ca-VO2])/[Hb]) ≤ 0.85 and VO2max < 85% predicted in the absence of a cardiac or pulmonary mechanical limit, determined by historical aCPET within 24 months of screening and confirmed reduction in skeletal muscle citrate synthase activity.
      • 女性受试者未怀孕且至少满足以下一个条件：o 非有生育能力的女性 (WOCBP)
        • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after final IP administration.
      • Female participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after final IP administration.
      • Female participant must not donate ova starting at first dose of IP and throughout the study period and for 28 days after final IP 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 28 days after final IP administration.
      • Male participant must not donate sperm during the treatment period and for 28 days after final 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 final 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。
      Maximize排除标准
      • Participant has signs and/or symptoms due to a cerebellar, pyramidal, extrapyramidal or other nonmyopathic process (e.g., cerebellar dysfunctions, movement disorder) that would interfere in any nontrivial manner with aCPET or SHAPE Test.
      • 受试者在筛选前 28 天或 5 个半衰期内（以时间较长者为准）接受过任何试验性治疗。- 受试者存在任何不适合参加研究的情况。- Participant has used moderate or strong inducers of CYP3A, CYP2C8 and CYP2C19 within the 3 months prior to day -1.
      • Participant has cardiac troponin I (cTnI) > ULN (or cardiac troponin T > ULN if cTnI is not available) at screening.
      • Participant has estimated glomerular filtration rate (eGFR) calculated by the modification of diet in renal disease equation < 60 mL/min per 1.73 m^2 at screening.
      • Participant has at screening: total bilirubin (TBL) > upper limit of normal (ULN) or transaminase(s) (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > ULN in the absence of elevations in creatine kinase.
      • Participant has diabetes mellitus (types 1 or 2).
      • Participant has mental conditions such as schizophrenia, bipolar disorder or major depressive disorder that has not been under control within 1 year prior to screening.
      • Participant has severe behavioral or cognitive problems that preclude participation in the study.
      • Participant has a history of suicide attempt, suicidal behavior or has any suicidal ideation within 1 year prior to screening that meets criteria at a level of 4 or 5 by using the Columbia-Suicide Severity Rating Scale (C-SSRS) or who is at significant risk to commit suicide.
      • Participant has undergone an inpatient hospitalization within the 30 days prior to the randomization or has a planned hospitalization or a surgical procedure during the study, which may affect the study assessments.
      • Participant has clinically significant respiratory disease and/or cardiac disease (medical history or current clinical findings) or prior interventional cardiac procedure (e.g., left heart catheterization which resulted in angioplasty/percutaneous coronary intervention, balloon valvuloplasty, etc.) within 3 months prior to randomization.
      • Participant has a pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device, or has a mean corrected QT interval using Fridericia’s formula (QTcF) > 450 msec for male participants and > 470 msec for female participants at screening or randomization. If QTcF exceeds these limits, 1 additional triplicate ECG can be taken on the same day in order to determine the participant’s eligibility.
      • Participant has ECG evidence of acute ischemia, atrial fibrillation or active conduction system abnormalities at screening, with the exception of any of the following:
        • First degree atrioventricular (AV)-block
        • Second degree AV-block type 1 (Mobitz type 1/Wenckebach type)
        • Right bundle branch block
      • Participant has a seizure disorder that may interfere with their ability to complete all study requirements.
      • Participant has an active malignancy or any other cancer from which the participant has been disease-free for < 5 years.
      • Participant has a solid organ transplant and is currently receiving treatment with therapy for immunosuppression.
      • Participant has a positive serology test for human immunodeficiency virus, hepatitis B or hepatitis C infection at screening.
      • Participant has previously received ASP0367.
      • Participant has a history of active substance abuse within 1 year prior to randomization.
      • Participant has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the participant tests positive for cotinine at screening or on day -1.
      • 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.
      • 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.
      • Participant has used any PPAR ligands such as fibrates and thiazolidinediones (e.g., clinofibrate, clofibrate, fenofibrate, gemfibrozil, pioglitazone, rosiglitazone) within 4 weeks prior to randomization.
      • Participant has used mestinon within 2 weeks prior to randomization.
      • Participant has initiated the use of coenzyme Q10 (CoQ10), carnitine, creatine or other mitochondrial-focused supplements within 4 weeks prior to randomization.
      • Participant has initiated an exercise regimen within 4 weeks prior to randomization.
      • Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
      • Participant has a positive result for SARS-CoV-2 polymerase chain reaction (PCR) test 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”。

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      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。若您在本网站未找到任何试验选择，我们建议您访问在线公共注册网站，例如 ClinicalTrials.gov 查看各种可参与的临床试验。

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