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AZD3293TQT

CompletedPhase 1

AZD3293 Thorough QT Study in Healthy Male Volunteers

A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects

Lead sponsor

AstraZeneca

Asset

Lanabecestat

Listed sites

1

Recruiting sites

-

Enrollment

52

actual

Study population

Alzheimer’s disease

Key I/E criteria

Age 18-55Male

Primary endpoint

Effect of a single dose of AZD3293 low dose

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

Org study IDD5010C00008
NCT IDNCT02040987

Timeline

Milestones

Study start2014-01 (month precision)
Study first posted2014-01-20estimated
Primary completion2014-05actual (month precision)
Study completion2014-05actual (month precision)
Last update posted2014-07-03estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

1. Provision of signed, written and dated informed consent prior to any study-specific procedures

2. Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements

3. Healthy male subjects aged 18 to 55 years

4. Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30

5. Clinically normal findings on physical examination in relation to age, as judged by the investigator

Exclusion criteria

1. History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study

2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

3. History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder

4. History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury

5. History of psychotic disorder among first degree relatives

Endpoints (6)

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
3
Other (unclassified)
3

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures

Time frame:Up to 69 days

event count, event

Secondary/protocol endpoint

Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects

Time frame:Up to 69 days

time to event, event

Secondary/protocol endpoint

The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)

Time frame:Up to 69 days

descriptive

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.

Time frame:Up to 69 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.

Time frame:Up to 69 days

descriptive

Other/protocol endpoint/low confidence

The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters

Time frame:Up to 69 days

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.