Clinical trial NCT02040987: AZD3293 Thorough QT Study in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Thorough QT study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2014-01-20
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A thorough QT study of AZD3293

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.
timeFrame: Up to 69 days
Secondary outcomes:
measure: The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.
timeFrame: Up to 69 days
measure: The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures
timeFrame: Up to 69 days
measure: Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects
timeFrame: Up to 69 days
measure: The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)
timeFrame: Up to 69 days
Other outcomes:
measure: The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters
timeFrame: Up to 69 days
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: Parexel ECPU Baltimore
name: Ronald Goldwater, MD
role: PRINCIPAL_INVESTIGATOR
References: