NCT05248672

Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

A Phase 1 Study to Assess the Pharmacokinetics of Different Multiple Dose Regimens of CT1812 in Older Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.

Detailed description

Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35 days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical Research Unit where they will continue to receive study drug and complete safety assessments, PK and CSF draws, until day 16 when they will be discharged.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	CT1812	Study Drug

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2022-02-21
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study