CompletedPhase 1

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

Lead sponsor

Nxera Pharma UK Limited

Asset

HTL0009936

Listed sites

Recruiting sites

Enrollment

108

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoints

•Adverse Events, as a measure of safety and tolerability•Changes in Safety Lab parameters as a measure of safety and tolerability•Changes in vital signs as a measure of safety and tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2013-002307-34

Org study ID9936-101

NCT IDNCT02291783

Timeline

Milestones

Study start2013-11 (month precision)

Primary completion2014-07actual (month precision)

Study completion2014-07actual (month precision)

Study first posted2014-11-14estimated

Last update posted2017-06-20actual

Assets

Drug assets

HTL0009936

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

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

Time frame:Part 1 - 1h, 2h,3h post dose

concentration, descriptive

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

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

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

event count, event

Primary/protocol endpoint

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

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.

descriptive

Primary/protocol endpoint

Changes in vital signs as a measure of safety and tolerability

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.

descriptive

Primary/protocol endpoint

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

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.

change from baseline, event

Secondary/protocol endpoint

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

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.

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic measures to assess the food effect as measured by ANOVA

Time frame:Pre-dose, multiple time points to 24h, and at 12h, 24h and 5 to 7 days post dose.

descriptive

Secondary/protocol endpoint

Pharmacokinetic measures in urine in young males and elderly male and female subjects as measured by amount of urine excreted at collection intervals

Time frame:Pre-dose,multiple 4h collection intervals to 24h post dose on select dosing days to Day 10 for multiple dosing.

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Pharmacodynamic response as measured by pupillometry

Time frame:Multiple time points Day1 to 6h post dose Part 1 only.

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamic response as measured by Bond and Lader visual analogue scale

Time frame:Day 1 at multiple timepoints to 24h post dose.

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamic response as measured by changes in qEEG and Event Related Potentials (ERP)

Time frame:Screening, Day-1, Day 4, Day 9 multiple dosing regimen only

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.