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

NCT03698695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2020-01-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Theranexus

    lead INDUSTRY

Principal Investigators

  • Régis Bordet, Prof. · CHU Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2019-10-20
Completion
2019-12-20

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03698695 on ClinicalTrials.gov