NCT05225389

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cognition Therapeutics · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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)

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	300 mg [C14] CT1812	Single dose of 300 mg CT1812 with microtracer dose of \[C14\]

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-01-17
• Completion: 2022-01-24
• First posted: 2022-02-04
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study