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Completed

NCT Number: NCT00672984

Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Normal Subjects

Treatment and study plan

immediate release guanfacine hydrochloride

Drug

Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.

Other names: Tenex

moxifloxacin

Drug

Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.

Other names: Avelox

Placebo

Drug

Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Primary outcomes

  1. Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1

    Time frame: 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.

  2. Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6

    Time frame: 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.

  3. Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1

    Time frame: 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.

  4. Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6

    Time frame: 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.

  5. Change From Baseline in Heart Rate (HR) at Tmax on Day 1

    Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)

  6. Change From Baseline in Heart Rate (HR) at Tmax on Day 6

    Time frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)

  7. Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1

    Time frame: 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).

  8. Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 6, 2008
Registry last updated
Jun 14, 2021

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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