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

Heptares Therapeutics

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: HTL0009936; Drug: HTL0009936 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291783

2013-002307-34 (EudraCT Number)

9936-101

Details and patient eligibility

About

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.

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

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 2 patient groups, including a placebo group

HTL0009936

Experimental group

Description:

HTL0009936 single and multiple ascending oral doses.

Treatment:

Drug: HTL0009936

HTL0009936 Placebo

Placebo Comparator group

Description:

HTL0009936 matching placebo

Treatment:

Drug: HTL0009936 placebo