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

April 10, 2023 updated by: Cognition Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) in plasma
Time Frame: Day 13 and 15.
Cmax: Maximum observed plasma concentration occurring at Tmax
Day 13 and 15.
Pharmacokinetics (PK) in plasma
Time Frame: Day 13 and 15.
Tmax: The first time to maximum observed concentration sampled during a dosing interval.
Day 13 and 15.
Pharmacokinetics (PK) in plasma
Time Frame: Day 13 and 15.
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
Time Frame: Day 13 and 15.
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
Time Frame: Day 13 and 15.
AUC 0-24h: AUC from time 0 to 24 hours post-dose.
Day 13 and 15.
Pharmacokinetics (PK) in plasma
Time Frame: Day 13 and 15.
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
Time Frame: Day 13 and 15.
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
Time Frame: Day 13 and 15.
AUC_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last.
Day 13 and 15.
Pharmacokinetics (PK) in plasma
Time Frame: Day 13 and 15.
λz : Terminal elimination phase rate constant.
Day 13 and 15.
Pharmacokinetics (PK) in plasma
Time Frame: Day 13 and 15.
t½: Terminal phase half-life.
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
Cmax - Maximum observed plasma concentration occurring at Tmax.
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
Tmax -The first time to maximum observed concentration sampled during a dosing interval.
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
Cavg,ss - Average plasma concentration at steady-state interval.
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
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).
Time Frame: Day 13 and 15.
Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval.
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
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).
Time Frame: Day 13 and 15.
λz- Terminal elimination phase rate constant
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
t½ - Terminal phase half-life
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1
Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Time Frame: Day 13 and 15.
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
Time Frame: Day 13 and 15.
CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15
Day 13 and 15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cognition Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anthony Caggiano, MD, Cognition Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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