Back to resultsAZD3293 Thorough QT Study in Healthy Male Volunteers (AZD3293TQT)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD3293
AZD3293
Placebo
Moxifloxacin
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease focused on measuring Thorough QT study
Eligibility Criteria
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study-specific procedures
- Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements
- Healthy male subjects aged 18 to 55 years
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Exclusion Criteria:
- 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
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
- History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- History of psychotic disorder among first degree relatives
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
AZD3293 dose A
AZD3293 dose B
Placebo
Moxifloxacin
Arm Description
AZD3293 therapeutic dose oral solution (low dose)
AZD3293 supratherapeutic dose oral solution (high dose)
Placebo oral solution
Moxifloxacin tablet
Outcomes
Primary Outcome Measures
The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Secondary Outcome Measures
The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.
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
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
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)
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.
Full Information
NCT ID
NCT02040987
First Posted
January 17, 2014
Last Updated
July 2, 2014
Sponsor
AstraZeneca
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT02040987
Brief Title
AZD3293 Thorough QT Study in Healthy Male Volunteers
Acronym
AZD3293TQT
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Parexel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Thorough QT study
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD3293 dose A
Arm Type
Experimental
Arm Description
AZD3293 therapeutic dose oral solution (low dose)
Arm Title
AZD3293 dose B
Arm Type
Experimental
Arm Description
AZD3293 supratherapeutic dose oral solution (high dose)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral solution
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Moxifloxacin tablet
Intervention Type
Drug
Intervention Name(s)
AZD3293
Other Intervention Name(s)
beta secretase inhibitor
Intervention Description
AZD3293 oral solution - one single dose (low dose).
Intervention Type
Drug
Intervention Name(s)
AZD3293
Intervention Description
AZD3293 oral solution - one single dose (high dose).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral solution - one single dose
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Description
Moxifloxacin tablet - one single dose
Primary Outcome Measure Information:
Title
The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.
Description
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Time Frame
Up to 69 days
Secondary Outcome Measure Information:
Title
The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.
Description
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula.
Time Frame
Up to 69 days
Title
The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures
Description
Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables
Time Frame
Up to 69 days
Title
Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects
Description
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
Time Frame
Up to 69 days
Title
The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)
Description
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.
Time Frame
Up to 69 days
Other Pre-specified Outcome Measures:
Title
The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters
Description
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Time Frame
Up to 69 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of signed, written and dated informed consent prior to any study-specific procedures
Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements
Healthy male subjects aged 18 to 55 years
Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Exclusion Criteria:
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
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
History of psychotic disorder among first degree relatives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Goldwater, MD
Organizational Affiliation
Parexel ECPU Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
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AZD3293 Thorough QT Study in Healthy Male Volunteers
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