AZD3293 Thorough QT Study in Healthy Male Volunteers (AZD3293TQT)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: AZD3293; Drug: Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040987

D5010C00008

Details and patient eligibility

About

A thorough QT study of AZD3293

Full description

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

Enrollment: 52 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 4 patient groups, including a placebo group

AZD3293 dose A

Experimental group

Description:

AZD3293 therapeutic dose oral solution (low dose)

Treatment:

Drug: AZD3293

Drug: AZD3293

AZD3293 dose B

Experimental group

Description:

AZD3293 supratherapeutic dose oral solution (high dose)

Treatment:

Drug: AZD3293

Drug: AZD3293

Placebo

Placebo Comparator group

Description:

Placebo oral solution

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin tablet

Treatment:

Drug: Moxifloxacin