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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2019-12-20

Brief Summary

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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.

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Detailed Description

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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

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Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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THN201

THN201: Donepezil 5mg capsule and Mefloquine 10mg capsule once daily for 15 days

Group Type EXPERIMENTAL

THN 201

Intervention Type DRUG

THN 201: Donepezil 5 mg and Mefloquine 10 mg/d

Donepezil

Donepezil 5mg capsule and Mefloquine placebo capsule once daily for 15 days

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

Donepezil 5 mg/d and Mefloquine placebo

Placebo

Donepezil placebo capsule and Mefloquine placebo capsule once daily for 15 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Donepezil placebo and Mefloquine placebo

Interventions

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THN 201

THN 201: Donepezil 5 mg and Mefloquine 10 mg/d

Intervention Type DRUG

Donepezil

Donepezil 5 mg/d and Mefloquine placebo

Intervention Type DRUG

Placebo

Donepezil placebo and Mefloquine placebo

Intervention Type DRUG

Other Intervention Names

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Donepezil Mefloquine

Eligibility Criteria

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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.
* Contraindication for the use of Aricept® or for one of its excipients.
* Contraindication for the use of piperidine derivative compounds or for other cholinesterase inhibitors.
* Contraindication for the use of Lariam® or for one of its excipients.
* Contraindication for the use of scopolamine S.C. injection.
* History or presence of drug or alcohol abuse (alcohol consumption \> 21 units / week).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes