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NNI-362 in Healthy Older Adults

Recruiting

This Phase I study will examine the safety, tolerability, and pharmacokinetics of single and multiple doses of NNI-362 in healthy older adults. NNI-362 is being investigated as a potential treatment for Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 72 Years All Yes
August 1, 2019
April 1, 2020
56

  • Reasonably good health as determined from medical history, vital signs measurements, physical examination, screening laboratory results, and electrocardiogram
  • Well-controlled, chronic, and stable medical conditions (e.g., high blood pressure, osteoarthritis, noninsulin dependent diabetes, osteoporosis, gout, Paget's disease, hypothyroidism) will not be exclusionary if not expected to interfere with participant safety or the study
  • Negative urine screen for drugs of abuse within 24 hours study drug doses
  • Body mass index of 18 to 30 and total body weight greater than 106 pounds

  • Women of childbearing potential
  • Pregnant or breastfeeding
  • Significant laboratory test result, including abnormal liver enzyme, serum creatinine, hemoglobin, white blood cell, or platelet levels
  • Significant medical illness, including chronic obstructive pulmonary disease, sleep apnea, heart arrhythmia, congestive heart failure, valvular or ischemic heart disease, pulmonary high blood pressure, kidney or urinary tract disorder, active peptic ulcer disease, gastrointestinal bleeding, inflammatory bowel disease, chronic pancreatitis, liver disease (excluding Gilbert's syndrome), and 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 nonmetastatic basal cell carcinoma)
  • History of seizure activity other than early childhood
  • Any traumatic brain injury in adulthood
  • Current smoker or nicotine user or quit within past 2 months
  • Active substance abuse
  • Glomerular filtration rate (a measure of kidney performance) less than 50 mL/min based on Cockcroft-Gault calculation
  • Difficulty swallowing

NNI-362 is a small molecule drug being studied for its potential to stimulate neurons in order to stop or slow the cognitive impairment associated with Alzheimer's disease. Participants in this study will be randomly assigned to take a liquid dose of either a placebo or study drug in escalating doses of 10 mg, 20 mg, and 60 mg.

Name City State Zip Status Primary Contact
Parexel, International
Glendale California 91206 Recruiting Parexel
814-254-1600
study.losangeles@parexel.com

Neuronascent, Inc.

  • National Institute on Aging (NIA)

Name Phone Email
Parexel International 814-254-1600 study.losangeles@Parexel.com

NCT04074837

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