Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers (COG0107)

This is an interventional basic science trial for Alzheimer Disease Read More

Inclusion Criteria:

• Men and Women 50-80 years of age, inclusively
• In good health as determined by the Investigator with no clinically significant abnormalities
• Weight between 50.0 and 100.0 kg, inclusive at Screening
• No suicidal ideation
• No active depression
• Living independently at home or in a community setting
• Able to swallow CT1812 capsule or capsules
• Non-smoker with no history of using tobacco or any nicotine-containing products
• Subjects with negative serology for HIV, Hepatitis B, and C
• Negative results for drugs of abuse, cotinine, and alcohol
• Negative test results for COVID-19
• Willing to comply with Clinical Pharmacology Unit's COVID-19 policies

Exclusion Criteria:

• Any chronic medical condition which, in the opinion of the investigator, might pose a safety risk to the subject or interfere with study interpretation
• Subject with active or recent infection requiring antibiotic therapy
• Medical history of vasculitis or any autoimmune disease
• Any recent hospitalization
• Subjects living in a continuous care nursing facility
• Any contraindication to a lumbar puncture
• Subjects with self-reported history of major depression
• History of diabetes
• Intake of drugs or substances potentially involved in clinically significant induction or inhibition of CYP3A4 or P-gp mediated drug interactions with CT1812
• Intake of investigational drug prior to study drug administration on Day 1
• Participation in an investigational device study prior to study drug administration on Day 1
• Grapefruit, grapefruit juice, and Seville oranges/juice must be avoided within 14 days prior to dosing and throughout the course of the study
• Suspected or known drug or alcohol abuse,
• Excessive consumption of coffee, tea, cola, or other caffeinated beverages
• Loss or donation of blood; nation of bone marrow or peripheral stem cells; or donation of plasma
• Venous access considered inadequate; history or evidence of adverse symptoms associated with phlebotomy or blood donation
• Suspected or known allergy to any component of the study treatments
• Employee or family member of the Investigator, study site personnel, or Sponsor
• A subject with any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation will be excluded