Cognitive ImpairmentPhase 1NCT03698695
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers
A Phase 1 study testing THN 201 and Donepezil in people with Cognitive Impairment and Alzheimer Disease, run by Theranexus at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Alzheimer Disease
- What is being tested?
- THN 201 and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 7 sitesFrance
- Study dates
- 27 Sep 2018to 20 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Bordeaux
Bordeaux
CHU Clermont Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble
CHU Lille
Lille
CHU Marseille
Marseille
Biotrial
Rennes
CHU Toulouse
Toulouse
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Cognitive Impairment, Alzheimer Disease
- Being tested
- THN 201, Donepezil, Placebo
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THN 201Drug
Also called Donepezil, Mefloquine
THN 201: Donepezil 5 mg and Mefloquine 10 mg/d
DonepezilDrug
Donepezil 5 mg/d and Mefloquine placebo
PlaceboDrug
Donepezil placebo and Mefloquine placebo
| Study group | Role | What they receive |
|---|---|---|
| THN201 | Experimental | THN201: Donepezil 5mg capsule and Mefloquine 10mg capsule once daily for 15 days Receives: Drug: THN 201 |
| Donepezil | Active comparator | Donepezil 5mg capsule and Mefloquine placebo capsule once daily for 15 days Receives: Drug: Donepezil |
| Placebo | Placebo comparator | Donepezil placebo capsule and Mefloquine placebo capsule once daily for 15 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: Cognitive function measured with the Cognitive Drug Research (CDR) test battery
Main variable: Power of attention is the sum of the speed scores (msec) from three tests: Simple Reaction Time, Choice Reaction Time, and Digital Vigilance. Low values indicate better performance
Measured: 15 days
Secondary outcomes (1)
Safety Adverse events
Number of subjects with spontaneously reported treatment related adverse events
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start27 Sep 2018
- Primary completion20 Oct 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranexus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Régis Bordet, Prof., Principal investigator, CHU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698695
- Sponsor's protocol ID
- THN201-101
- Status last verified
- Jan 2020
- First submitted
- 2 Oct 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03698695
- Acronym / sponsor ID
- THN201-101
- Conditions
- Cognitive Impairment, Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- TheranexusIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THN201 | Experimental | Drug: THN 201THN201: Donepezil 5mg capsule and Mefloquine 10mg capsule once daily for 15 days |
| Donepezil | Active comparator | Drug: DonepezilDonepezil 5mg capsule and Mefloquine placebo capsule once daily for 15 days |
| Placebo | Placebo comparator | Drug: PlaceboDonepezil placebo capsule and Mefloquine placebo capsule once daily for 15 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THN 201Also: Donepezil, MefloquineTHN 201: Donepezil 5 mg and Mefloquine 10 mg/d | Drug | THN201 |
| DonepezilDonepezil 5 mg/d and Mefloquine placebo | Drug | Donepezil |
| PlaceboDonepezil placebo and Mefloquine placebo | Drug | Placebo |
Primary outcome
Pharmacodynamics: Cognitive function measured with the Cognitive Drug Research (CDR) test battery
Time frame: 15 days
Main variable: Power of attention is the sum of the speed scores (msec) from three tests: Simple Reaction Time, Choice Reaction Time, and Digital Vigilance. Low values indicate better performance
1 secondary outcome
Safety Adverse events
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Régis Bordet, Prof. principal investigator
CHU Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THN 201 and Donepezil in people with Cognitive Impairment and Alzheimer Disease, run by Theranexus at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics: Cognitive function measured with the Cognitive Drug Research (CDR) test battery (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.