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| ID | Type | Description | Link |
|---|---|---|---|
| SB1AG073028 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT1812 | Experimental | Investigational Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 mg [C14] CT1812 | Drug | Single dose of 300 mg CT1812 with microtracer dose of [C14] |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose through 96 hours postdose |
| 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. | Predose through 144 hours postdose |
| 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. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
| 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. | Predose through 144 hours postdose |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of disease that, in the opinion of the PI/designee, may influence the outcome of the study within 4 weeks before dosing
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.
Any history of GI surgery that may affect PK profiles of CT1812
Has evidence of a clinically significant abnormality in physical examination findings, vital signs, or clinical laboratory determinations at the Screening visit or Check-in.
Has a clinically significant ECG abnormality at the Screening visit or Check-in.
Estimated creatinine clearance <80 ml/min/1.73 m2 at the Screening visit.
Known history of clinically significant allergy to CT1812 or excipients at the Screening visit.
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.
Has a history of alcohol use disorder within the 2 years before the Screening visit.
Positive urine drug or alcohol results at the Screening visit or Check in.
Positive cotinine result at the Screening visit.
Unable to refrain from or anticipates the use of:
Donation of blood or significant blood loss within 56 days prior to dosing.
Plasma donation within 7 days prior to dosing.
Poor peripheral venous access.
Recent history (within 2 weeks of Day 1) of abnormal bowel movements, such as diarrhea, loose stools, or constipation.
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.
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.
Has previously participated in a CT1812 investigational study.
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.
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.
Participation in another clinical study within 30 days prior to dosing.
Healthy, adult, males eligible for the study
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Caggiano, MD | Cognition Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
Subjects were required to have a negative COVID-19 polymerase chain reaction (PCR) test in order to be enrolled in the study, as per the requirements outlined in the COVID-19 Clinical Pharmacology Unit Management Strategy and Study Risk Assessment documents.
Subjects were admitted to the clinical research unit (CRU).
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 mg | Single oral dose of 300 mg CT1812 (2 capsules) with a microtracer dose of ~1 µCi [14C]-CT1812 (1 capsule). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg | Single oral dose of 300 mg CT1812 (2 capsules) with a microtracer dose of ~1 µCi [14C]-CT1812 (1 capsule). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For the calculation of summary statistics, values that are below the limit of quantitation (BLQ) of 0.00005 μg/mL are treated as 0.00 before the first quantifiable concentration and as missing elsewhere. No values were reported for the 120, 144, 168 hours timepoints. Three subjects were discontinued from the study after testing positive for COVID-19. | Posted | Mean | Standard Deviation | μg/mL | Predose through 96 hours postdose |
|
15 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 mg | Single oral dose of 300 mg CT1812 (2 capsules) with a microtracer dose of ~1 µCi [14C]-CT1812 (1 capsule). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID 19 | Infections and infestations | MedDra 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer, Head of R&D | Cogntion Therapeutics Inc | 914-221-6730 | acaggiano@cogrx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2021 | Jun 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2022 | Jun 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
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Open-label, single-dose study
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| 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). |
| 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. | Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose |
| 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). | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
| 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). | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
| 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). | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
| 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) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
| Predose through 144 hours postdose |
| 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. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | 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. | For the calculation of summary statistics, values that are below the limit of quantitation (BLQ) of 0.00005 μg/mL are treated as 0.00 before the first quantifiable concentration and as missing elsewhere. Three subjects were discontinued from the study after testing positive for COVID-19 | Posted | Mean | Standard Deviation | μg/mL | Predose through 144 hours postdose |
|
|
|
| Primary | 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. | For the calculation of summary statistics, values that are below the limits of quantitation (BLQ) ranging between 0.0261 - 0.0328 μg Eq/mL are treated as 0.00 before the first quantifiable concentration and as missing elsewhere. Three subjects were discontinued from the study after testing positive for COVID-19 | Posted | Mean | Standard Deviation | μg Eq/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
|
|
|
| Primary | 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. | For the calculation of summary statistics, values that are below the limits of quantitation (BLQ) ranging between 0.0368 - 0.0406 μg Eq/mL are treated as 0.00 before the first quantifiable concentration and as missing elsewhere. Three subjects were discontinued from the study after testing positive for COVID-19. No values were reported at 168 hours timepoint. | Posted | Mean | Standard Deviation | μg Eq/mL | Predose through 144 hours postdose |
|
|
|
| Primary | 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. | For the calculation of recovery parameters and summary statistics, concentration values that are below the limits.of quantitation (BLQ) ranging between 0.00205 to 0.00488 μg Eq/g are treated as 0.00. Three subjects were discontinued from the study after testing positive for COVID-19. | Posted | Mean | Standard Deviation | percentage of radioactive eliminated | 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). |
|
|
|
| Primary | 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. | For the calculation of recovery parameters and summary statistics of concentration data, concentration values that are below the limits of quantitation (BLQ) are treated as 0.00. Three subjects were discontinued from the study after testing positive for COVID-19. | Posted | Mean | Standard Deviation | percentage of radioactive eliminated | Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | ug*hr/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | ug*hr/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | μg Eq*hr/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | μg Eq*hr/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ratio | Predose through 144 hours postdose |
|
|
|
| Secondary | 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. | Single oral dose of 300 mg CT1812 (2 capsules) with a microtracer dose of ~1 µCi [14C]-CT1812 (1 capsule). | Posted | Number | Events | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| Headache | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
|
The Institution will not publish or present any Study Data, results, Study Inventions, or Sponsor Confidential Information without prior written approval from the Sponsor. Institution will keep confidential and not disclose any information provided by or on behalf of Sponsor or CRO or that is generated, discovered, or obtained by any Party as a result of the Study (other than patient medical records), including the Study results, Study Inventions and information related thereto.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Severe TEAEs |
|
| Related TEAEs |
|
| TEAEs Leading to Treatment Discontinuation |
|