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

Nxera Pharma UK Limited108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Alzheimer's Disease

Interventions

HTL0009936DRUG

Single dose

HTL0009936 placeboDRUG

Placebo single dose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Parexel Early Phase Clinical Unit

Harrow, Middlesex, United Kingdom

Outcomes

Primary Outcomes

Number of participants with Adverse Events, as a measure of safety and tolerability

AE reports include a description of the AE, date and time of onset and resolution, intensity, and relationship to IMP.

Time frame: From signing of informed consent up to 30 days after the final visit

Changes in Safety Lab parameters as a measure of safety and tolerability

Hematology, clinical chemistry, urinalysis

Time frame: Screening, Day-1, at select dosing days, and at 5 to 7 days post dose for single doseand 15 to 17 days post first dose in multiple dosing.

Changes in vital signs as a measure of safety and tolerability

Pulse rate,body temperature,blood pressure, and orthostatic changes.

Time frame: Screening, Day-1, at select dosing days and at 5 to 7 days post dose for single dose, and 15 to 17 days post first dose in multiple dosing.

Changes in 12-lead electrocardiograms as a measure of safety and tolerability

Change in ECG parameters

Time frame: Screening, pre-dose, at select dosing days and at 5 to 7 days post dose for single dose,and 15 to 17 days post first dose in multiple dosing.

Secondary Outcomes

Pharmacokinetic measures in plasma as measured by Peak plasma concentration (Cmax)

Peak plasma concentration (Cmax), time at occurrence of Cmax (tmax), Area under the plasma concentration versus time curve (AUC) 0-t, 0- infinity, percent of AUC 0-infinity, Cmax normalized by dose, AUC 0-t normalized for dose.

Time frame: Pre-dose, multiple time points to 24h, at select dosing days, and 5 to 7 days post dosefor single dose,and 15 to 17 days post first dose in multiple dosing.

Pharmacokinetic measures in cerebro spinal fluid (CSF) in young males as measured by max observed CSF (Cmax CSF)

Data from ClinicalTrials.gov

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