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”

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

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• 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.
• Drug: moxifloxacin
  • Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
• Drug: Placebo
  • Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Immediate-release Guanfacine HCl
• Active Comparator: Moxifloxacin HCl
• Placebo Comparator: Placebo

Primary Measures

• 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)
    Safety Issue?: Yes
• Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6
  • Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
    Safety Issue?: Yes
• Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1
  • Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
    Safety Issue?: Yes
• Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6
  • Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
    Safety Issue?: Yes
• Change From Baseline in Heart Rate (HR) at Tmax on Day 1
  • Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
    Safety Issue?: Yes
• Change From Baseline in Heart Rate (HR) at Tmax on Day 6
  • Time Frame: Baseline and Tmax (time of subject-specific maximum plasma concentration)
    Safety Issue?: Yes
• 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)
    Safety Issue?: Yes
• 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)
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

Inclusion Criteria:

• Healthy Normal Subjects

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Shire Pharmaceutical Development

Overall Clinical Trial Officials and Contacts

Robert S. Kahn, MD Principal Investigator Charles River Clinical Services Northwest Inc.  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672984

Study ID Number: SPD503-112

ClinicalTrials.gov Identifier: NCT00672984

Health Authority: United States: Food and Drug Administration

FDA recall information

FDA Medical Product Safety Alerts

FDA-approved label

Synopsis of study results