Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: 300 mg [C14] CT1812
Intervention description: Single dose of 300 mg CT1812 with microtracer dose of [C14]
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-dose study
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        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.