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CompletedNCT05225389COG0108Updated Jul 21, 2023Results posted

Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects

A Phase 1 interventional study of 300 mg [C14] CT1812 in Alzheimer Disease, sponsored by Cognition Therapeutics. Completed at 1 site in United States. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Cognition Therapeutics · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812

Read the detailed description

Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812 in 8 healthy male subjects

Subjects will be screened 28-days prior to dosing to determine eligibility.

Eligible subjects will be admitted to the clinical research unit (CRU) on Day -1. On Day 1, subjects will receive a single dose of CT1812 with a microtracer dose of [14C] CT1812. Whole blood, plasma, urine and fecal samples will be collection during the confinement period. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

Subjects will be and discharged from the CRU following completion of procedures 168 hours post dose (Day 8)

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 8 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Cognition Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy, adult, male, 19 - 55 years of age
  2. Male subjects must follow protocol specified contraception guidance as described in the protocol
  3. Continuous non smoker who has not used tobacco/nicotine containing products for at least 3 months prior to dosing.
  4. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at the Screening visit (subjects must not have experienced a weight loss or gain of >10% within 4 weeks of dosing).
  5. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI/designee at the Screening visit.
  6. History of a minimum of 1 bowel movement per day.
  7. Able to swallow multiple capsules.
  8. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Evidence of disease that, in the opinion of the PI/designee, may influence the outcome of the study within 4 weeks before dosing
  2. Clinically significant illness, in the opinion of the PI/designee, that requires medical treatment within 8 weeks prior to dosing, or a clinically significant infection that requires medical treatment within 4 weeks prior to dosing.
  3. Any history of GI surgery that may affect PK profiles of CT1812
  4. Has evidence of a clinically significant abnormality in physical examination findings, vital signs, or clinical laboratory determinations at the Screening visit or Check-in.
  5. Has a clinically significant ECG abnormality at the Screening visit or Check-in.
  6. Estimated creatinine clearance \<80 ml/min/1.73 m2 at the Screening visit.
  7. Known history of clinically significant allergy to CT1812 or excipients at the Screening visit.
  8. Has been diagnosed with acquired immune deficiency syndrome, or tests positive for human immunodeficiency virus (HIV), Hepatitis B virus surface antigen (HBsAg), or Hepatitis C virus (HCV) at the Screening visit.
  9. Has a history of alcohol use disorder within the 2 years before the Screening visit.
  10. Positive urine drug or alcohol results at the Screening visit or Check in.
  11. Positive cotinine result at the Screening visit.

  12. Unable to refrain from or anticipates the use of:

    • Any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing except for those allowed in the protocol
    • Any drugs known to be significant inducers of CYP2D6 and CYP3A4 for 28 days prior to dosing.
  13. Donation of blood or significant blood loss within 56 days prior to dosing.
  14. Plasma donation within 7 days prior to dosing.
  15. Poor peripheral venous access.
  16. Recent history (within 2 weeks of Day 1) of abnormal bowel movements, such as diarrhea, loose stools, or constipation.
  17. Has exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
  18. Has participated in a radiolabeled drug study where exposures are known to the PI within the previous 3 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the PI within the previous 6 months prior to admission to the clinic for this study.
  19. Has previously participated in a CT1812 investigational study.
  20. Evidence or history of active suicidal thoughts in the 6 months preceding the screening visit; or have a history of a suicide attempt in the previous 2 years, or more than 1 lifetime suicide attempt; or are at serious suicide risk per the PIs clinical judgment.
  21. Has any condition that would, in the opinion of the PI/designee or Sponsor, make the subject unsuitable for the study or is, in the opinion of the PI/designee, not likely to complete the study for any reason.
  22. Participation in another clinical study within 30 days prior to dosing.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    CT1812

    Investigational Drug

    Drug: 300 mg [C14] CT1812

Interventions

  • Drug300 mg [C14] CT1812

    Single dose of 300 mg CT1812 with microtracer dose of \[C14\]

06

What researchers measure

Primary outcomes

  1. Plasma CT1812 Concentration at 96 Hours Timepoint

    Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

    Time frame: Predose through 96 hours postdose

  2. Plasma M6/CP199 Concentration at 144 Hours Timepoint

    Plasma concentrations of M6/CP199 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

    Time frame: Predose through 144 hours postdose

  3. Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint

    Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

  4. Whole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint

    The analysis of Whole Blood Total Radioactivity Concentration of CT1812-Equivalents was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

    Time frame: Predose through 144 hours postdose

  5. Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine

    Cumulative radioactive dose (Cum%Dose) excreted in the urine was determined using Liquid Scintillation Counting (LSC) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

    Time frame: Predose and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours postdose, and every 24 hours (pooled) until Day 8 (168 hours postdose).

  6. Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces

    Cumulative radioactive dose (Cum%Dose) excreted in the feces was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

    Time frame: Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose

  7. CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter

    Plasma CT1812 Concentration were measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

  8. M6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter

    M6/CP199 Plasma Concentration was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. M6/CP199 plasma concentrations were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

  9. Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

    Plasma Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC).

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

  10. Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

    Whole Blood Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC)

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose

Secondary outcomes

  1. Whole Blood:Plasma Total Radioactivity Partitioning Ratios Over Time up to 144 Hours Timepoint

    This measure describes the percentage of TRA in whole blood relative to plasma. The fraction of \[14C\]-radioactivity associated with whole blood and plasma and with red blood cells and other cellular components of whole blood was determined by using the concentration of \[14C\]-radioactivity in whole blood and plasma.

    Time frame: Predose through 144 hours postdose

  2. Number of TEAEs, Related TEAEs, SAEs, and Related SAEs

    Incidence and Severity of Adverse Events. All AEs that occurred during this clinical trial were coded using the Medical Dictionary for Regulatory Activities (MedDRA®), Version 24.1.

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours

07

Results

Posted Jul 21, 2023

Participant flow

Subjects were admitted to the clinical research unit (CRU).

Participant flow — Overall Study
Milestone300 mg
Started8
Completed5
Not completed3
Withdrew: Three participants were discontinued by the investigator on day 7 due to positive covid-19 tests.3

Outcome measures

PrimaryPlasma CT1812 Concentration at 96 Hours Timepoint

Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Time frame:
Predose through 96 hours postdose
Reported as:
Mean · μg/mL
Plasma CT1812 Concentration at 96 Hours Timepoint
μg/mL300 mg
Plasma CT1812 Concentration at 96 Hours Timepoint0.0000707 ± 0.0000240
PrimaryPlasma M6/CP199 Concentration at 144 Hours Timepoint

Plasma concentrations of M6/CP199 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Time frame:
Predose through 144 hours postdose
Reported as:
Mean · μg/mL
Plasma M6/CP199 Concentration at 144 Hours Timepoint
μg/mL300 mg
Plasma M6/CP199 Concentration at 144 Hours Timepoint0.00001501 ± 0.0001370
PrimaryPlasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint

Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Reported as:
Mean · μg Eq/mL
Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint
μg Eq/mL300 mg
Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint0.08720 ± 0.068380
PrimaryWhole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint

The analysis of Whole Blood Total Radioactivity Concentration of CT1812-Equivalents was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Time frame:
Predose through 144 hours postdose
Reported as:
Mean · μg Eq/mL
Whole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint
μg Eq/mL300 mg
Whole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint0.04413 ± 0.0086904
PrimaryCumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine

Cumulative radioactive dose (Cum%Dose) excreted in the urine was determined using Liquid Scintillation Counting (LSC) following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Time frame:
Predose and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours postdose, and every 24 hours (pooled) until Day 8 (168 hours postdose).
Reported as:
Mean · percentage of radioactive eliminated
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine
percentage of radioactive eliminated300 mg
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine81.13 ± 2.9789
PrimaryCumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces

Cumulative radioactive dose (Cum%Dose) excreted in the feces was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects.

Time frame:
Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose
Reported as:
Mean · percentage of radioactive eliminated
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces
percentage of radioactive eliminated300 mg
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces19.29 ± 3,2123
PrimaryCT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter

Plasma CT1812 Concentration were measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Reported as:
Mean · ug*hr/mL
CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
ug*hr/mL300 mg
CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter0.6636 ± 0.31014
PrimaryM6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter

M6/CP199 Plasma Concentration was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. M6/CP199 plasma concentrations were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Reported as:
Mean · ug*hr/mL)
M6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
ug*hr/mL)300 mg
M6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter48.46 ± 9.8619
PrimaryPlasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

Plasma Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC).

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Reported as:
Mean · μg Eq*hr/mL
Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
μg Eq*hr/mL300 mg
Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter85.24 ± 11.436
PrimaryWhole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

Whole Blood Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (\~1 μCi) \[14C\]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC)

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Reported as:
Mean · μg Eq*hr/mL
Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
μg Eq*hr/mL300 mg
Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter52.51 ± 11.371
SecondaryWhole Blood:Plasma Total Radioactivity Partitioning Ratios Over Time up to 144 Hours Timepoint

This measure describes the percentage of TRA in whole blood relative to plasma. The fraction of \[14C\]-radioactivity associated with whole blood and plasma and with red blood cells and other cellular components of whole blood was determined by using the concentration of \[14C\]-radioactivity in whole blood and plasma.

Time frame:
Predose through 144 hours postdose
Reported as:
Mean · ratio
Whole Blood:Plasma Total Radioactivity Partitioning Ratios Over Time up to 144 Hours Timepoint
ratio300 mg
Whole Blood:Plasma Total Radioactivity Partitioning Ratios Over Time up to 144 Hours Timepoint0.4519 ± 0.11051
SecondaryNumber of TEAEs, Related TEAEs, SAEs, and Related SAEs

Incidence and Severity of Adverse Events. All AEs that occurred during this clinical trial were coded using the Medical Dictionary for Regulatory Activities (MedDRA®), Version 24.1.

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours
Reported as:
Number · Events
Number of TEAEs, Related TEAEs, SAEs, and Related SAEs
Events300 mg
All TEAEs5
Mild TEAEs3
Moderate TEAEs2
Severe TEAEs0
Related TEAEs0
TEAEs Leading to Treatment Discontinuation2

Adverse events

Collected over 15 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
300 mg0/8 (0%)0/8 (0%)3/8 (37.5%)
Most frequent other events
Most frequent other events
Event300 mg
COVID 19Infections and infestations2/8
HeadacheNervous system disorders1/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)300 mg
Mean33.6 ± 11.72
Sex: Female, Male
Sex: Female, Male(Participants)300 mg
Female0
Male8
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)300 mg
Black or African American4
White4
Weight
Weight(Kg)300 mg
Mean81.91 ± 12.908
Height
Height(cm)300 mg
Mean180.3 ± 3.54
Body Mass Index
Body Mass Index(kg/m^2)300 mg
Mean25.233 ± 3.5198
08

Study locations

1 site
  • Celerion
    Lincoln, Nebraska 68502, United States
09

References and documents

Study documents

  • Study protocol · Dec 15, 2021
  • Statistical analysis plan · Jan 25, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05225389
Lead sponsor
Cognition Therapeutics
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Dec 31, 2021
Primary completion
Jan 17, 2022
Completion
Jan 24, 2022
Results posted
Jul 21, 2023
Last update
Jul 21, 2023

Study contacts

Anthony Caggiano, MD
study director · Cognition Therapeutics Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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