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

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).