NCT03698695

A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers

A Double Blind, Placebo-controlled, Randomized, 15-day Treatment, Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil Administered Orally to Healthy Male Volunteers Including a Scopolamine Challenge

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Theranexus · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study explores the safety, pharmacodynamics and pharmacokinetics of THN201 a combination of donepezil and mefloquine to improve cognitive function in healthy male volunteers after impairment by a scopolamine challenge.

Detailed description

This is a double-blind, 3-arm, parallel group study of 15 days duration including a scopolamine challenge at D15. Healthy male subjects will receive daily doses of THN201 (donepezil 5 mg and mefloquine), donepezil 5 mg or placebo and one subcutaneous injection of scopolamine 0.5 mg on D15. Cognitive function, EEG and P300 will be assessed at baseline and before and after scopolamine challenge at D15. A final safety evaluation will be performed 2 weeks after the end of the treatment period. Pharmacokinetic assessments will be performed to obtain a time/concentration profile of donepezil and mefloquine.

Conditions

• Cognitive Impairment
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	THN 201	THN 201: Donepezil 5 mg and Mefloquine 10 mg/d
DRUG	Donepezil	Donepezil 5 mg/d and Mefloquine placebo
DRUG	Placebo	Donepezil placebo and Mefloquine placebo

Timeline

• Start date: 2018-09-27
• Primary completion: 2019-10-20
• Completion: 2019-12-20
• First posted: 2018-10-09
• Last updated: 2020-01-22

Locations

7 sites across 1 country: France