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Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05225389•Cognition Therapeutics

View on ClinicalTrials.gov

Summary

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

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)

Eligibility

Age

19 - 55 years

Sex

MALE

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

•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.
+14 more criteria

Locations (1)

Celerion

Lincoln, Nebraska, United States

Key Dates

Start Date

December 31, 2021

Primary Completion Date

January 17, 2022

Completion Date

January 24, 2022

Last Updated

July 21, 2023

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

300 mg [C14] CT1812

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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