COG0108

CompletedPhase 1Results posted

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

A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C] CT1812 in Healthy Adult Male Subjects

Lead sponsor

Cognition Therapeutics

Asset

CT1812

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 19-55•Male

Primary endpoints

•Plasma CT1812 Concentration•Plasma M6/CP199 Concentration•Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCOG0108

NCT IDNCT05225389

NihSB1AG073028

Timeline

Milestones

Study start2021-12-31actual

Primary completion2022-01-17actual

Study completion2022-01-24actual

Study first posted2022-02-04actual

Last update posted2023-07-21actual

Results first posted2023-07-21actual

Assets

Drug assets

CT1812

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age19 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

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

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.

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter

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

concentration, descriptive

Primary/protocol endpoint

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

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

concentration, descriptive

Primary/protocol endpoint

Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

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

concentration, descriptive

Primary/protocol endpoint

Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

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

concentration, descriptive

Primary/registry result

CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter

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

concentration, descriptive

Posted result

Group	Value (mean), ug*hr/mL	Standard deviation
300 mgn=8 Participants	0.6636	0.31014

Primary/registry result

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

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

concentration, descriptive

Posted result

Group	Value (mean), ug*hr/mL)	Standard deviation
300 mgn=8 Participants	48.46	9.8619

Primary/registry result

Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

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

concentration, descriptive

Posted result

Group	Value (mean), μg Eq*hr/mL	Standard deviation
300 mgn=8 Participants	85.24	11.436

Primary/registry result

Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter

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

concentration, descriptive

Posted result

Group	Value (mean), μg Eq*hr/mL	Standard deviation
300 mgn=8 Participants	52.51	11.371

Secondary/protocol endpoint

Number of TEAEs, Related TEAEs, SAEs, and Related SAEs

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

event count, event

Secondary/registry result

Number of TEAEs, Related TEAEs, SAEs, and Related SAEs

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

event count, event

Posted result

Group	Value (number), Events	Reported bounds
300 mgAll TEAEsn=8 Participants	5	-
Mild TEAEsn=8 Participants	3	-
Moderate TEAEsn=8 Participants	2	-
Severe TEAEsn=8 Participants	0	-
Related TEAEsn=8 Participants	0	-
TEAEs Leading to Treatment Discontinuationn=8 Participants	2	-

Other (unclassified)

14 endpoints

Primary/protocol endpoint/low confidence

Plasma CT1812 Concentration at 96 Hours Timepoint

Time frame:Predose through 96 hours postdose

concentration, descriptive

Primary/protocol endpoint/low confidence

Plasma M6/CP199 Concentration at 144 Hours Timepoint

Time frame:Predose through 144 hours postdose

concentration, descriptive

Primary/protocol endpoint/low confidence

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

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

concentration, descriptive

Primary/protocol endpoint/low confidence

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

Time frame:Predose through 144 hours postdose

concentration, descriptive

Primary/protocol endpoint/low confidence

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

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).

threshold achievement, improvement

Primary/protocol endpoint/low confidence

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

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

threshold achievement, improvement

Primary/registry result/low confidence

Plasma CT1812 Concentration at 96 Hours Timepoint

Time frame:Predose through 96 hours postdose

concentration, descriptive

Posted result

Group	Value (mean), μg/mL	Standard deviation
300 mgn=8 Participants	0.0000707	0.0000240

Primary/registry result/low confidence

Plasma M6/CP199 Concentration at 144 Hours Timepoint

Time frame:Predose through 144 hours postdose

concentration, descriptive

Posted result

Group	Value (mean), μg/mL	Standard deviation
300 mgn=8 Participants	0.00001501	0.0001370

Primary/registry result/low confidence

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

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

concentration, descriptive

Posted result

Group	Value (mean), μg Eq/mL	Standard deviation
300 mgn=8 Participants	0.08720	0.068380

Primary/registry result/low confidence

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

Time frame:Predose through 144 hours postdose

concentration, descriptive

Posted result

Group	Value (mean), μg Eq/mL	Standard deviation
300 mgn=8 Participants	0.04413	0.0086904

Primary/registry result/low confidence

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

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).

threshold achievement, improvement

Posted result

Group	Value (mean), percentage of radioactive eliminated	Standard deviation
300 mgn=8 Participants	81.13	2.9789

Primary/registry result/low confidence

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

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

threshold achievement, improvement

Posted result

Group	Value (mean), percentage of radioactive eliminated	Standard deviation
300 mgn=8 Participants	19.29	3,2123

Secondary/protocol endpoint/low confidence

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

Time frame:Predose through 144 hours postdose

threshold achievement, improvement

Secondary/registry result/low confidence

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

Time frame:Predose through 144 hours postdose

threshold achievement, improvement

Posted result

Group	Value (mean), ratio	Standard deviation
300 mgn=8 Participants	0.4519	0.11051

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.