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

A Phase 1 Study to Assess the Pharmacokinetics of Different Multiple Dose Regimens of CT1812 in Older Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: CT1812

Detailed Description

Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35 days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical Research Unit where they will continue to receive study drug and complete safety assessments, PK and CSF draws, until day 16 when they will be discharged.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 150 mg QD; CT1812 150 mg QD	Drug: CT1812; Study Drug
Experimental: 150 mg BID; CT1812 150 mg BID	Drug: CT1812; Study Drug
Experimental: 300 mg QD; CT1812 300 mg QD	Drug: CT1812; Study Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) in plasma	Cmax: Maximum observed plasma concentration occurring at Tmax	Day 13 and 15.
Pharmacokinetics (PK) in plasma	Tmax: The first time to maximum observed concentration sampled during a dosing interval.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	Ctau: Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).	Day 13 and 15.
Pharmacokinetics (PK) in plasma	AUC 0-12h: Area under the concentration-time curve (AUC) from time 0 to 12 hours post-dose.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	AUC 0-24h: AUC from time 0 to 24 hours post-dose.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	AUC 0-last: AUC from time 0 to the time of the last measurable concentration at 48 and 72 hours as applicable.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	AUC 0-inf: Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity, calculated using the observed value of the last non-zero concentration.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	AUC_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	λz : Terminal elimination phase rate constant.	Day 13 and 15.
Pharmacokinetics (PK) in plasma	t½: Terminal phase half-life.	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Cmax - Maximum observed plasma concentration occurring at Tmax.	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Tmax -The first time to maximum observed concentration sampled during a dosing interval.	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Cavg,ss - Average plasma concentration at steady-state interval.	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Ctau-Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval.	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	AUC-0-tau - Area under the concentration-time curve from time 0 to the end of the dosing interval (0-12 for the BID group; 0 - 24 for the QD groups) .	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	λz- Terminal elimination phase rate constant	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	t½ - Terminal phase half-life	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).	Cmax,cum - Accumulation ratio in Cmax, calculated as Cmax,ss/Cmax,D1	Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio	CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15	Day 13 and 15.

Collaborators and Investigators

• Sponsor: Cognition Therapeutics
• Investigators: Study Director: Anthony Caggiano, MD, Cognition Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: COG0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No