Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: immediate release guanfacine hydrochloride; Drug: moxifloxacin; Drug: Placebo

• Registration Number: NCT00672984
• Lead Sponsor: Shire

Brief Summary

To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-18
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-06
• Primary Completion: 2008-08-07
• Study Completion: 2008-08-07
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2009-11-13
• Results First Posted: 2009-12-21
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Healthy Normal Subjects

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate-release Guanfacine HCl	immediate release guanfacine hydrochloride	-
Moxifloxacin HCl	moxifloxacin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1	Baseline and Tmax (time of subject-specific maximum plasma concentration)	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).
Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1	Baseline, Tmax (time of subject-specific maximum plasma concentration)	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.
Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6	Baseline and Tmax (time of subject-specific maximum plasma concentration)	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.
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1	Baseline and Tmax (time of subject-specific maximum plasma concentration)	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.
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6	Baseline and Tmax (time of subject-specific maximum plasma concentration)	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.
Change From Baseline in Heart Rate (HR) at Tmax on Day 1	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 6	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6	Baseline and Tmax (time of subject-specific maximum plasma concentration)	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).

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1	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	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	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	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	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	pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose

Trial Locations

Locations (1)

Charles River Clinical Services Northwest, Inc.; 🇺🇸 Tacoma, Washington, United States