Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment

A Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of HTL0009936 in Healthy Subjects

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 the treatment of cognitive disorders.

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 the treatment of cognitive disorders. This study is a single ascending dose study.

Inclusion Criteria:

• 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 Criteria:

• 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