To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
83
Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, United States
Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1
QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time frame: Baseline, Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6
QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 1
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Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 6
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).
Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose
Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose