Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT03698695
Eligibility Criteria:
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).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03698695
Study Brief:
Protocol Section:
NCT03698695