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
single and multiple doses of NNI-362 in healthy aged population.
– Healthy aged volunteers of either sex between the ages of 50 and 72 inclusive at time
– 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.
– • Women of child-bearing potential, defined as premenopausal (unless the potential
research subject has previously undergone hysterectomy and/or bilateral
– 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
- Parexel, International, Glendale, California, United States, 91206