Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

NCT05248672 | Completed Phase 1 FDA Drug

• 1 other identifier: COG0107
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (22)

• 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.

Study Arms (3)

150 mg QD

EXPERIMENTAL

CT1812 150 mg QD

Drug: CT1812

150 mg BID

EXPERIMENTAL

CT1812 150 mg BID

Drug: CT1812

300 mg QD

EXPERIMENTAL

CT1812 300 mg QD

Drug: CT1812

Interventions

CT1812 DRUG

Study Drug

150 mg BID; 150 mg QD; 300 mg QD

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cognition Therapeutics: lead

Study Sites (1)

Accel Clinical Research

DeLand, Florida, 32720, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anthony Caggiano, MD

  Cognition Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Study

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: February 15, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)