Trial | NCT02291783  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    htl0009936 ...

  • Study Participants

    108
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.
Study Started
Nov 30
2013
Primary Completion
Jul 31
2014
Study Completion
Jul 31
2014
Last Update
Jun 20
2017

Drug HTL0009936

Single dose

  • Other names: 9936, HTL0009936

Drug HTL0009936 placebo

Placebo single dose

  • Other names: Placebo

HTL0009936 Experimental

HTL0009936 single and multiple ascending oral doses.

HTL0009936 Placebo Placebo Comparator

HTL0009936 matching placebo

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
No Results Posted