Loading clinical trials...

A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03698695•Theranexus

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•A body mass index (BMI), calculated as weight in kg/(height in m)², from 18 to 30 kg/m², inclusive
•Healthy as determined by the investigator after a comprehensive clinical assessment based on medical history, physical examination, clinical laboratory test results, vital sign measurements, blood pressure (BP), heart rate (HR) and digital 12-lead ECG readings (all results should be normal or, if out of range, they should be non-clinically significant as determined by the investigator)

Exclusion Criteria

•Any significant cardiovascular (e.g. heart failure), pulmonary (including asthma), hepatic, renal, respiratory (e.g. asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidaemia), immunologic, dermatological, haematological, neurologic, psychiatric disease, history of any clinically important drug allergy, systemic or presence of infectious disease.
•Current suicide risk or history of suicide risk (C-SSRS baseline: "yes" answer to items 4 and/or 5).
•Brain imaging (MRI) at screening showing anatomical or vascular abnormality of any type.
•EEG examination at screening showing abnormal (epileptiform) activities.
•Symptomatic hypotension,
•Participants with, or with a history of cardiac arrhythmia or cardiac disease or a personal or family history of long QT syndrome or a family history of sudden death.
•Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
•Antimalarial medicine intake or returning from a malaria-endemic area within the 12 last months before the first IMP administration.
•Planning to visit a country requiring antimalarial chemoprophylaxis during the study period.
•History of adverse reaction after a previous mefloquine intake.
+5 more criteria

Locations (7)

CHU Bordeaux

Bordeaux, France

CHU Clermont Ferrand

Clermont-Ferrand, France

CHU Grenoble

Grenoble, France

CHU Lille

Lille, France

CHU Marseille

Marseille, France

Biotrial

Rennes, France

CHU Toulouse

Toulouse, France

Key Dates

Start Date

September 27, 2018

Primary Completion Date

October 20, 2019

Completion Date

December 20, 2019

Last Updated

January 22, 2020

Enrollment

152

ACTUAL participants

Conditions

Cognitive ImpairmentAlzheimer Disease

Interventions

THN 201

DRUG

Donepezil

DRUG

Placebo

DRUG

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

View study

RECRUITINGNA

Choline to Improve Malnutrition and Enhance Cognition

NCT06154174

Severe Acute MalnutritionCognitive Impairment+2 more

View study

RECRUITINGNA

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sense4Safety Intervention

Choline to Improve Malnutrition and Enhance Cognition

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment