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: G
• Active Comparator: M
• Placebo Comparator: P

Primary Measures

• Qt/QTc difference from time matched baseline
  • Time Frame: During any of 3 arms (Moxifloxacin, Placebo, or Immediate-Release Guanfacine) EKGs will be acquired during Day -1, for baseline, and Day 1 and Day 6 of treatment
    Safety Issue?: Yes

Secondary Measures

• Measure will be same via QT/QTc difference from baseline, but will be based on Holter (bin) data analysis method
  • Time Frame: During any of 3 arms (Moxifloxacin, Placebo, or Immediate-Release Guanfacine) EKGs will be acquired during Day -1, for baseline, and Day 1 and Day 6 of treatment Times: 30 min pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 and 24h post-dose
    Safety Issue?: Yes

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 September 04, 2008

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