CompletedPhase 1

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

Lead sponsor

Theranexus

Assets

Donepezil / THN 201

Listed sites

Recruiting sites

Enrollment

152

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-40•Male

Primary endpoint

•Pharmacodynamics

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03698695

Org study IDTHN201-101

Timeline

Milestones

Study start2018-09-27actual

Study first posted2018-10-09actual

Primary completion2019-10-20actual

Study completion2019-12-20actual

Last update posted2020-01-22actual

Assets

Drug assets

Donepezil THN 201

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexMale

Healthy volunteersAccepted

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).

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Fluid / digital biomarkers

Safety / tolerability / PK

Global cognition

1 endpoint

Primary/protocol endpoint

Pharmacodynamics: Cognitive function measured with the Cognitive Drug Research (CDR) test battery

Time frame:15 days

descriptive

Fluid / digital biomarkers

2 endpoints

Other/protocol endpoint

Pharmacodynamics measured by quantitative EEG (qEEG)

Time frame:15 days

descriptive

Other/protocol endpoint

Pharmacodynamics measured by event related EEG potentials (P300)

Time frame:15 days

concentration, descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Safety Adverse events

Time frame:29 days

event count, event

Other/protocol endpoint

Pharmacokinetics Plasma concentration of donepezil and mefloquine

Time frame:29 days

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.