Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

Healthy Volunteers Clinical Trial

Official title:

A Phase I, Randomized, Gender Stratified, Double-Blind, Placebo- and Positive-Controlled, Three Period Crossover Trial to Assess the Effect of Guanfacine Hydrochloride on QT/QTc Interval in Healthy Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672984
• Other study ID #: SPD503-112
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2008
• Est. completion date: August 7, 2008

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 7, 2008
• Est. primary completion date: August 7, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy Normal Subjects

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• immediate release guanfacine hydrochloride
Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.
• moxifloxacin
Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
• Placebo
Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Locations

Country	Name	City	State
United States	Charles River Clinical Services Northwest, Inc.	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Tmax (time of subject-specific maximum plasma concentration)
Primary	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.	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Primary	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.	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Primary	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.	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Primary	Change From Baseline in Heart Rate (HR) at Tmax on Day 1		Baseline and Tmax (time of subject-specific maximum plasma concentration)
Primary	Change From Baseline in Heart Rate (HR) at Tmax on Day 6		Baseline and Tmax (time of subject-specific maximum plasma concentration)
Primary	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).	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Primary	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).	Baseline and Tmax (time of subject-specific maximum plasma concentration)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   FDA recall information
•   FDA-approved label