NCT00672984

Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-18
• Primary completion: 2008-08-07
• Completion: 2008-08-07
• First posted: 2008-05-06
• Last updated: 2021-06-14
• Results posted: 2009-12-21

Locations

1 site across 1 country: United States