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

NCT05225389 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: COG0108SB1AG073028
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Secondary Outcomes (2)

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

  Predose through 144 hours postdose

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

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

Study Arms (1)

CT1812

EXPERIMENTAL

Investigational Drug

Drug: 300 mg [C14] CT1812

Interventions

300 mg [C14] CT1812 DRUG

Single dose of 300 mg CT1812 with microtracer dose of \[C14\]

CT1812

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Healthy, adult, males eligible for the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Cognition Therapeutics: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Carbon-14

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer, Head of R&D
• Organization: Cogntion Therapeutics Inc

acaggiano@cogrx.com

914-221-6730

Study Officials

• Anthony Caggiano, MD

  Cognition Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single-dose study

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 4, 2022
• Study Start: December 31, 2021
• Primary Completion: January 17, 2022
• Study Completion: January 24, 2022
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2023-07

Locations

US (1)