NL-OMON48314已完成不适用
Evaluating the safety, tolerability, and pharmacodynamic properties of IW-6463 in healthy elderly subjects. - Safety, tolerability, and PD of IW-6463 in healthy elderly
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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
- •Each participant must meet each of the following criteria to be eligible for
- •enrollment in this study.
- •1. Signed an informed consent form (ICF) before any study-specific procedures
- •are performed.
- •2. Is fluent in the written and spoken language of the local ICF (ie, Dutch).
- •3. Age is *65 years at the day of first dose administration.
- •4. Ambulatory and in good health as defined by the absence of evidence of any
- •clinically relevant active or chronic disease following detailed medical and
- •surgical history review and a complete physical examination including vital
- •signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- •a. Note: The Investigator will determine whether a particular finding is
- •clinically significant. In making this determination, the Investigator will
- •consider whether the particular finding could prevent the participant from
- •performing any of the protocol-specified assessments, could represent a
- •condition that would exclude the participant from the study, could represent a
- •safety concern if the participant participates in the study, or could confound
- •the study-specified assessments
- •5. Able to understand the commitments of the study, to communicate effectively
- •with the investigator and site staff and agrees to adhere to all study
- •requirements, including the lifestyle restrictions.
- •6. Able to undergo MRI scanning procedures.
- •7. Body mass index is *18 and <32 kg/m2 at the Screening Visit.
- •8. Supine systolic blood pressure (BP) is in the range of 100 to 160 mmHg,
- •inclusive; and supine diastolic BP is in the range of 60 to 95 mmHg, inclusive,
- •at the Screening Visit.
- •Note: Screening BP will be the average of 2 measurements obtained with an
- •appropriately sized cuff at 2 minute intervals after the participant has been
- •resting quietly in a supine position for *5 minutes.If the average systolic BP
- •is between 150 and
- •160 mmHg at Screening, confirmation excluding a history of hypertension will be
- •obtained. No more than 4 subjects with systolic BP in this range will be
- •enrolled in each
- •9. Agrees to refrain from making any major lifestyle changes (e.g., start a new
- •diet or change an exercise pattern) from the time of signature of the ICF until
- •after the Follow-up Period.
- •10. Female participants must be postmenopausal. A postmenopausal state is
- •defined as no menses for *12 consecutive months without an alternative medical
- •cause. A high follicle-stimulating hormone (FSH) level at screening (>40 IU/L
- •or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal
- •11. Male participants who have not been surgically sterilized by vasectomy
- •(conducted *60 days before the Screening Visit or confirmed via sperm analysis)
- •must agree to use *1 of the following effective contraception methods from the
- •date of signing the ICF until 90 days after receiving his final study drug dose:
- •a. Completely abstain from heterosexual intercourse with non-menopausal women *
- •b. If heterosexually active with women of reproductive potential, use, or have
- •their sexual partners use:
- •* Intrauterine device *or*
- •* Combination of 2 highly effective birth control methods (e.g., condom with
- •spermicide + diaphragm or cervical cap; hormonal contraceptive [e.g., oral or
- •transdermal patch or progesterone implant] + barrier method) *or*
- 另有 1 项未显示
排除标准
- •A participant who meets any of the following criteria will be excluded from the
- •1. Clinically relevant history of abnormal physical or mental health
- •interfering with the study as determined from the medical history review and
- •the physical examinations obtained during the screening visit and/or at the
- •start of the first study day for each period as judged by the investigator
- •including (but not limited to), neurological, psychiatric, endocrine,
- •cardiovascular (including recent myocardial infarction), respiratory,
- •gastrointestinal, hepatic, renal disorder or presence of narrow-angle glaucoma)
- •psychiatric (including history of clinical depression or suicidal ideation); or
- •neurological disorder.
- •2. 12-lead ECG at the Screening Visit demonstrating severe bradycardia (heart
- •rate [HR] <40 beats per minute) or average QT interval corrected for HR using
- •Fridericia*s formula (QTcF) *450 msec for men or *470 msec for women.
- •3. Family history of short QT syndrome or long QT syndrome.
- •4. History or clinical evidence of any disease and/or existence of any surgical
- •or medical condition that might interfere with the absorption, distribution,
- •metabolism, or excretion of the study drugs.
- •5. History of severe allergies, or history of an anaphylactic reaction to
- •prescription or non-prescription drugs or food.
- •6. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core
- •antigen antibody
- •[anti-HBc], hepatitis C antibody (HCV Ab), or human immunodeficiency virus
- •antibody (HIV Ab) at screening.
- •7. Clinically significant hypersensitivity or allergy to any of the inactive
- •ingredients contained in the active or placebo drug products.
- •8. Clinically relevant positive urine drug screen (UDS) or alcohol test at
- •screening and/or upon admission to the Clinical Research Unit (CRU) before each
- •dosing period.
- •9. Presence or history (within 3 months of screening) of alcohol abuse
- •confirmed by medical history, or daily alcohol consumption exceeding 2 standard
- •drinks per day on average for females or exceeding 3 standard drinks per day on
- •average for males (1 standard drink=10 grams of alcohol), and the inability to
- •refrain from alcohol during the visits until discharge from the CRU (alcohol
- •consumption will be prohibited during study confinement).
- •10. Any concurrent disease or condition that could interfere with, or for which
- •the concomitant treatment might interfere with, the conduct of the study or
- •that would, in the opinion of the Investigator, pose an unacceptable risk to
- •the participant in this study.
- •11. Received IW-6463 in a prior study, participated in an investigational drug
- •trial in the 3 months prior to administration of the initial dose of study drug
- •or in more than 4 trials in the prior 12 months, is planning to receive another
- •investigational drug at any time during the study, has an active
- •investigational medical device currently implanted, and/or is planning to have
- •an investigational medical device implanted at any time during the study.
- •12. Donation or loss of blood of more than 500 mL within 3 months (males) or 4
- •months (females) prior to screening and/or donated any plasma within 2 weeks of
- •the Screening Visit.
- •13. Elevated levels (ie, >1.5× the upper limit of normal as defined by the
- •laboratory) at the Screening Visit or at Day 1 of alanine aminotrans
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