Research Site
Baltimore, Maryland, United States
NCT Number: NCT02040987
A thorough QT study of AZD3293
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Baltimore, Maryland, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AZD3293 oral solution - one single dose (low dose).
Other names: beta secretase inhibitor
Placebo oral solution - one single dose
Moxifloxacin tablet - one single dose
Time frame: Up to 69 days
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Time frame: Up to 69 days
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula.
Time frame: Up to 69 days
Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables
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
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.
Time frame: Up to 69 days
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
AstraZeneca
Industry
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
Acronym: AZD3293TQT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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