Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

• Status: Recruiting
• Trial end date: 2022-04-21
• Target enrollment: 0
• Participant gender: All

Summary

This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cognition Therapeutics

Criteria

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