NL-OMON42111已完成不适用
A two-part study to evaluate the safety, pharmacokinetics, pharmacodynamics of HTL0009936 in healthy elderly and elderly with below average cognitive functioning. - Safety, PK and PD of HTL0009936.
Heptares Therapeutics Ltd.0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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
- •1.Healthy male and female subjects from 65 and older, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis;;2. BMI between 18 and 34 kg/m2, inclusive;;3. Ability to communicate well with the investigator in the Dutch language; ;4. Female participants should be post-menopausal;;5. Able to participate and willing to give written informed consent and to comply with the study restrictions; and;6. Intermediate (IM) or extensive (EM) metabolizer as determined by CYP2D6 genotype.;Additional inclusion criteria for Part B of the study only;1. A score of <=-1 SD on at least one of the following screening tests: 15-word learning test (memory), category fluency; animals (executive functioning) and adaptive tracking (attention);;2. Willing and able to perform the cognitive tests, as evidenced by performance on the training session of the cognitive tests.
排除标准
- •1. Legal incapacity or inability to understand or comply with the requirements of the study;;2. Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history taking and 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;;3. Any disease associated with cognitive impairment, including but not limited to schizophrenia and dementia;;4. Clinically relevant abnormal laboratory results, ECG and vital signs, or physical findings at screening and/or at the start of the first study day for each period;;5. Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg;;6. Notable resting bradycardia (HR < 45 bpm) or tachycardia (HR > 100 bpm) at screening or baseline visit;;7. A QTcF > 450 or < 300 msec at resting ECG at screening or baseline visit; ;8. Personal or family history of congenital long QT syndrome or sudden death;;9. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;;10. Aspartate transaminase (AST), alanine transaminase (ALT), gamma glutamyl transferase (GGT) or total bilirubin levels >1.5 times the upper limit of normal at screening;;11. Evidence of significant renal insufficiency, indicated by a glomerular filtration rate lower than the lower limit of normal (related to age) at screening;;12. 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), or a positive breath alcohol test at screening or upon admission to the Clinical Research Unit, and the inability to refrain from alcohol use from 24 hours before screening, dosing and each scheduled visit until discharge from the clinical research unit;;13. Use of tobacco and/or nicotine-containing products within 90 days of dosing;;14. Habitual and heavy consumption of caffeinated beverages (more than 8 cups of coffee or equivalent/day) at screening and/or unable to refrain from use of (methyl) xanthine (e.g. coffee, tea, cola, chocolate) from 24 hours prior to dosing until discharge from the CRU;;15. Positive urine drug screen (UDS) or alcohol or cotinine test at screening and/or pre-dose;;16. Concomitant use of drugs that are metabolised by and/or are inhibitors of CYP2D6 (e.g., quinidine, paroxetine, fluoxetine) or inhibitors/inducers of CYP3A4 (e.g., ketoconazole, ritonavir) from 21 days prior to study drug administration;;17. Concomitant use of drugs that are substrates for the organic cation transporter 2 (OCT 2), including amantadine, amiloride, cimetidine, dopamine, famotidine, memantine, metformin, pindolol, procainamide, ranitidine, varenicline, oxaliplatin and dofetilide;;18. Intake of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 3 days before admission to the CRU and while subjects are confined to the CRU;;19. Subject is unable to refrain from the use of concomitant medication which, in the opinion of the investigator, interferes with their ability to participate in the trial,
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