Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment
NCT ID: NCT02291783
Last Updated: 2017-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
108 participants
INTERVENTIONAL
2013-11-30
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 1 Study Investigating Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects
NCT02546310
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
NCT03987295
Safety, Tolerability, and Pharmacokinetics Study of NDX-1017
NCT03298672
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
NCT05262023
Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care
NCT03456349
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HTL0009936
HTL0009936 single and multiple ascending oral doses.
HTL0009936
Single dose
HTL0009936 Placebo
HTL0009936 matching placebo
HTL0009936 placebo
Placebo single dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HTL0009936
Single dose
HTL0009936 placebo
Placebo single dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy subject free from any clinically significant illness or disease
* Female subjects must be ≥65 years
Exclusion Criteria
* History of hypersensitivity to study drug
* History of epilepsy or seizures
* Subject with previous history of suicidal behavior
* Subjects with significant hearing impairment
* Subjects with an abnormal EEG
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nxera Pharma UK Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Annelize Koch, MBChB
Role: PRINCIPAL_INVESTIGATOR
Parexel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parexel Early Phase Clinical Unit
Harrow, Middlesex, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-002307-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9936-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.