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

Completed · Phase 1

Conditions studied: Alzheimer Disease

In brief

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

Key facts

Study ID

NCT05225389

Run by

Cognition Therapeutics

People needed

8

Starts

2021-12-31

Expected to finish

2022-01-24

Last updated by the study team

2023-07-21

Who can join

Age: 19 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy, adult, male, 19 - 55 years of age
• Male subjects must follow protocol specified contraception guidance as described in the protocol
• Continuous non smoker who has not used tobacco/nicotine containing products for at least 3 months prior to dosing.
• 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).
• 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.
• History of a minimum of 1 bowel movement per day.
• Able to swallow multiple capsules.
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if…

• 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:
• 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.
• 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.

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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