Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers

Exclusion Criteria

• •• 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