Status:
COMPLETED
Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment
Lead Sponsor:
Nxera Pharma UK Limited
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor agonist intended for ...
Detailed Description
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor agonist intended for ...
Eligibility Criteria
Inclusion
- Body mass index of ≥19 and ≤ 30kg/m²
- Healthy subject free from any clinically significant illness or disease
- Female subjects must be ≥65 years
Exclusion
- Subject who is predicted to be a CYP2D6 poor or ultra rapid metabolizer
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT02291783
Start Date
November 1 2013
End Date
July 1 2014
Last Update
June 20 2017
Active Locations (1)
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1
Parexel Early Phase Clinical Unit
Harrow, Middlesex, United Kingdom, HA1 3UJ