AZD3293 Thorough QT Study in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A thorough QT study of AZD3293

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

NCT00979316

Alzheimer Disease

COMPLETED PHASE1

Multiple Dose Study of TRx0037

NCT01253499

Alzheimer's Disease

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects

NCT00687141

Alzheimer's Disease

COMPLETED PHASE1

Safety, Tolerability, and Pharmacokinetics Study of NDX-1017

NCT03298672

Alzheimer Disease

COMPLETED PHASE1

A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients

NCT01795339

Healthy Elderly Volunteers Mild-to-moderate Alzheimer's Disease Patients

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD3293 dose A

AZD3293 therapeutic dose oral solution (low dose)

Group Type EXPERIMENTAL

AZD3293

Intervention Type DRUG

AZD3293 oral solution - one single dose (low dose).

AZD3293 dose B

AZD3293 supratherapeutic dose oral solution (high dose)

Group Type EXPERIMENTAL

AZD3293

Intervention Type DRUG

AZD3293 oral solution - one single dose (high dose).

Placebo

Placebo oral solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral solution - one single dose

Moxifloxacin

Moxifloxacin tablet

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Moxifloxacin tablet - one single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD3293

AZD3293 oral solution - one single dose (low dose).

Intervention Type DRUG

AZD3293

AZD3293 oral solution - one single dose (high dose).

Intervention Type DRUG

Placebo

Placebo oral solution - one single dose

Intervention Type DRUG

Moxifloxacin

Moxifloxacin tablet - one single dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

beta secretase inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes