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CompletedPhase 1

Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation

A Phase 1 Relative Bioavailability Study in Healthy CYP2D6 Intermediate (IM) and Extensive Metaboliser (EM) Subjects, Designed to Evaluate the Pharmacokinetic (PK) Profile of HTL0009936 Following Single Dose Administration of Modified Release (MR) Prototype Formulations

Asset

HTL0009936

Listed sites

1

Recruiting sites

-

Enrollment

14

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-65

Primary endpoints

•Tlag•Frel•Tmax

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 number2015-004921-16
Org study ID9936-104
NCT IDNCT02710188

Timeline

Milestones

Study start2016-02 (month precision)
Study first posted2016-03-16estimated
Primary completion2016-07actual (month precision)
Study completion2016-08actual (month precision)
Last update posted2016-10-18estimated

Assets

Drug assets

HTL0009936

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Healthy males \& females
•Aged 18 to 65 years
•Body mass index of 18.0 to 35.0 kg/m2
•CYP2D6 (intermediate or extensive metabolizer)

Exclusion criteria

•Subjects with a resting heart rate (HR) >90 bpm, and/or systolic blood pressure (BP) >150 mmHg, and/or diastolic BP >90 mmHg
•Subjects with QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms (males) or >470 ms (females)
•Personal or family history of long QT syndrome or sudden death
•Subjects who are CYP2D6 (poor or ultra-rapid metabolizer)

Endpoints (14)

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
8
Other (unclassified)
6

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Tmax

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint

AUC (0-last)

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint

AUC (0-inf)

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint

AUC%extrap

Time frame:14 weeks

threshold achievement, event

Primary/protocol endpoint

T1/2

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint

Dose normalized AUC

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint

Dose normalized Cmax

Time frame:14 weeks

concentration, descriptive

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Tlag

Time frame:14 weeks

concentration, descriptive

Primary/protocol endpoint/low confidence

Frel

Time frame:14 weeks

descriptive

Primary/protocol endpoint/low confidence

Concentration of HTL0009936 at 6 hours post dose (C6)

Time frame:6 hours post dose

concentration, descriptive

Primary/protocol endpoint/low confidence

Lambda-z

Time frame:14 weeks

descriptive

Primary/protocol endpoint/low confidence

Concentration of HTL0009936 at 12 hours post dose (C12)

Time frame:12 hours post dose

concentration, descriptive

Primary/protocol endpoint/low confidence

Concentration of HTL0009936 at 24 hours post dose (C24)

Time frame:24 hours post dose

concentration, descriptive

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.