AZD3293 Thorough QT Study in Healthy Male Volunteers (AZD3293TQT)
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|ClinicalTrials.gov Identifier: NCT02040987|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : July 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: AZD3293 Drug: Placebo Drug: Moxifloxacin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|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 Start Date :||January 2014|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: AZD3293 dose A
AZD3293 therapeutic dose oral solution (low dose)
AZD3293 oral solution - one single dose (low dose).
Other Name: beta secretase inhibitor
Experimental: AZD3293 dose B
AZD3293 supratherapeutic dose oral solution (high dose)
AZD3293 oral solution - one single dose (high dose).
Placebo Comparator: Placebo
Placebo oral solution
Placebo oral solution - one single dose
Active Comparator: Moxifloxacin
Moxifloxacin tablet - one single dose
- The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo. [ Time Frame: Up to 69 days ]The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
- The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
- The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters [ Time Frame: Up to 69 days ]The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040987
|United States, Maryland|
|Baltimore, Maryland, United States|
|Principal Investigator:||Ronald Goldwater, MD||Parexel ECPU Baltimore|