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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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 the treatment of cognitive disorders.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Heptares Therapeutics Limited

Criteria

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