NCT05525780

Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 Intramuscular Depot and Aricept® Oral Tablets (Pfizer Canada Inc.) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: G2GBio, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers. And, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of GB-5001 IM depot and the oral Aricept® (donepezil hydrochloride) tablet by PK modeling.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	GB-5001	Depending on the cohort, volume will be varied to administer.
DRUG	Placebo	A matched volume of placebo product will be administered to each subject in each cohort.
DRUG	Oral cohort	Single dose of Aricept tablet

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-06-02
• Completion: 2023-06-02
• First posted: 2022-09-02
• Last updated: 2023-07-13

Locations

1 site across 1 country: Canada