Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
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.
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
Sites / Locations
- Parexel, International
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo
NNI-362, 10 mg
NNI-362, 20 mg
NNI-362, 60 mg
NNI-362, 120 mg
NNI-362, 240 mg
Placebo liquid suspension.
NNI-362 at 10 mg in liquid suspension
NNI-362 at 20 mg in liquid suspension
NNI-362 at 60 mg in liquid suspension
NNI-362 at 120 mg in liquid suspension
NNI-362 at 240 mg in liquid suspension