---
title: Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment
nct_id: NCT02291783
overall_status: COMPLETED
phase: PHASE1
sponsor: Nxera Pharma UK Limited
study_type: INTERVENTIONAL
primary_condition: "Alzheimer's Disease"
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02291783.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02291783"
ct_last_update_post_date: 2017-06-20
last_seen_at: "2026-05-12T07:05:45.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment

**Official Title:** A Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of HTL0009936 in Healthy Subjects

**NCT ID:** [NCT02291783](https://clinicaltrials.gov/study/NCT02291783)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** Nxera Pharma UK Limited
- **Conditions:** Alzheimer's Disease
- **Start Date:** 2013-11
- **Completion Date:** 2014-07
- **CT.gov Last Update:** 2017-06-20

## Brief 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **HTL0009936** (EXPERIMENTAL) — HTL0009936 single and multiple ascending oral doses.
- **HTL0009936 Placebo** (PLACEBO_COMPARATOR) — HTL0009936 matching placebo

## Interventions

- **HTL0009936** (DRUG) — Single dose
- **HTL0009936 placebo** (DRUG) — Placebo single dose

## Primary Outcomes

- **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)_ — AE reports include a description of the AE, date and time of onset and resolution, intensity, and relationship to IMP.
- **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.)_ — Hematology, clinical chemistry, urinalysis
- **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.)_ — Pulse rate,body temperature,blood pressure, and orthostatic changes.
- **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 in ECG parameters

## Secondary Outcomes

- **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.)_
- **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)_
- **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.)_
- **Pharmacodynamic response as measured by pupillometry** _(time frame: Multiple time points Day1 to 6h post dose Part 1 only.)_
- **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.)_
- **Pharmacodynamic response as measured by Bond and Lader visual analogue scale** _(time frame: Day 1 at multiple timepoints to 24h post dose.)_
- **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)_

## Locations (1)

- Parexel Early Phase Clinical Unit, Harrow, Middlesex, United Kingdom

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.parexel early phase clinical unit|harrow|middlesex|united kingdom` — added _(2026-05-12)_

---

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