Alzheimer's Disease
Conditions
Keywords
Thorough QT study
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
Interventions
DRUGAZD3293
AZD3293 oral solution - one single dose (low dose).
DRUGPlacebo
Placebo oral solution - one single dose
DRUGMoxifloxacin
Moxifloxacin tablet - one single dose
Sponsors
Parexel
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo. | Up to 69 days | The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo. | Up to 69 days | The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula. |
| The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures | Up to 69 days | Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables |
| Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects | Up to 69 days | AUC(0-t): Area under the concentration versus time curve from time 0 to the time of the last quantifiable concentration to be calculated by a combination of linear and logarithmic trapezoidal methods (linear up-log down) Cmax: Maximum observed plasma concentration obtained directly from the concentration vs. time data tmax: Time to reach Cmax following dose, obtained directly from the concentration vs. time data |
| The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB) | Up to 69 days | RR: The time between corresponding points on 2 consecutive R waves on ECG. PR: ECG interval measured from the onset of the P wave to the onset of the QRS complex. QRS: ECG interval measured from the onset of the QRS complex to the J point. QT: ECG interval measured from the onset of the QRS complex to the offset of the T wave. QTcB: The heart rate corrected QT calculated using Bazett's formula. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters | Up to 69 days | The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula |
Countries
United States
Outcome results
None listed