NCT04074837已完成1 期
Phase1a, Randomized Placebo-controlled, Single and Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNI-362 in Healthy Aged Volunteers 50 to 72 Years of Age
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Measure number of treatment related adverse events following single and multiple dosing of NNI-362.
研究概览
简要总结
The purpose of this study is to examine the safety, tolerability and pharmacokinetics of single and multiple doses of NNI-362 in healthy aged population.
详细描述
The early clinical development strategy consists of the initial evaluation of safety and tolerability of NNI-362. This FIH Phase I includes single and multiple ascending dose studies in healthy aged volunteers. Assessment of suicidal ideation/behavior will be performed at baseline and at all study visits and on days of inpatient confinement in conformance with FDA recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcome Assessor)
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy aged volunteers of either sex between the ages of 50 and 72 inclusive at time of screening.
- •Subjects must be in reasonably good health as determined by investigator based on medical history, vital signs measurements, physical examination, screening laboratory results and ECG.
- •Normal age-related findings as well as well-controlled, chronic and stable medical conditions (e.g., hypertension, osteoarthritis, non-insulin dependent diabetes mellitus, osteoporosis, gout, Paget's disease, hypothyroidism) will not be exclusionary if they are not expected to compromise subject safety, study conduct, or study objectives.
- •Non-interacting medications for stable allowable medical conditions will be allowed following review and approval by the medical monitor.
- •An adequate understanding of the requirements of the study, provision of written informed consent, and agreement to abide by the study restrictions.
- •Negative urine screen for drugs of abuse within 24 h before the administration of the first dose of study drug and in the multiple dose study upon readmission to the clinical unit from outpatient status.
- •Body Mass Index (BMI) of between 18 and 30 kg/m2 inclusive, and a total body weight greater than 48kg at screening.
排除标准
- •• Women of child-bearing potential, defined as premenopausal (unless the potential research subject has previously undergone hysterectomy and/or bilateral salpingo-oophorectomy)
- •Pregnant or breastfeeding
- •Any clinically significant hematology, chemistry, coagulation, or urinalysis value at screening and day -1 Abnormal liver enzymes (ALT and/or AST >1.5X ULN) at screening and day -1
- •Serum creatinine > ULN at screening and day -1
- •Hemoglobin <13 g/dL for males or <11.5 g/dL for females, leukocytes <3.0 X 103/uL, absolute neutrophil count <1000/uL, or platelets <150 X 103/uL at screening and day -1
- •Any significant medical illness that could compromise the interpretability of study data or affect subject safety including, but not necessarily limited to:
- •Chronic pulmonary disease or sleep apnea
- •Clinically significant cardiac arrhythmia (either at screening or based on history)
- •Congestive heart failure, valvular heart disease or ischemic heart disease
- •Pulmonary hypertension
- •Any disorder of the kidney or urinary tract
- •Active peptic ulcer disease, gastrointestinal bleeding, inflammatory bowel disease, chronic pancreatitis
- •Liver disease (excluding Gilbert's syndrome)
- •Any neurologic disorder other than chronic Bell's Palsy
- •History of malignancy that has not been cured or in complete remission for at least 10 years (excluding resected non-metastatic basal cell carcinoma)
- •History of seizure activity other than early childhood
- •Any traumatic brain injury in adulthood
- •Current smoker or nicotine user (quit less than 2 months)
- •Active substance abuse.
- •Glomerular filtration rate <50 mL/min based on Cockcroft-Gault calculation using ideal (lean) body weight or present weight.
- •Difficulty swallowing
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo liquid suspension.
干预措施: Placebo (Drug)
NNI-362, 10 mg
Active Comparator
NNI-362 at 10 mg in liquid suspension
干预措施: NNI-362 (Drug)
NNI-362, 20 mg
Active Comparator
NNI-362 at 20 mg in liquid suspension
干预措施: NNI-362 (Drug)
NNI-362, 60 mg
Active Comparator
NNI-362 at 60 mg in liquid suspension
干预措施: NNI-362 (Drug)
NNI-362, 120 mg
Active Comparator
NNI-362 at 120 mg in liquid suspension
干预措施: NNI-362 (Drug)
NNI-362, 240 mg
Active Comparator
NNI-362 at 240 mg in liquid suspension
干预措施: NNI-362 (Drug)
结局指标
主要结局
Measure number of treatment related adverse events following single and multiple dosing of NNI-362.
时间窗: 5 to 15 days
To examine the number of participants with treatment-related adverse events according to criteria of CTCAE v4.0
次要结局
- Measure Area Under the Curve with single and multiple dosing of NNI-362(48 hours)
- Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362.(48 hours)
研究者
研究点 (1)
Loading locations...
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