Guanfacine Immediate-Release Thorough QTc Study - Full Text View

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00672984

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: immediate release guanfacine hydrochloride Drug: moxifloxacin Drug: Placebo	Phase I

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

Resource links provided by NLM:

Drug Information available for: Guanfacine Guanfacine hydrochloride Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment:	83
Study Start Date:	April 2008
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
G: Experimental	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.
M: Active Comparator	Drug: moxifloxacin Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.
P: Placebo Comparator	Drug: Placebo Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Normal Subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672984

Locations

United States, Washington
Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, United States

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Robert S. Kahn, MD

Charles River Clinical Services Northwest Inc.

More Information

No publications provided

Responsible Party:	Shire Pharmaceutical ( Gerald Tremblay, M.D. )
Study ID Numbers:	SPD503-112
Study First Received:	May 2, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00672984 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shire Pharmaceutical Development:

QT/QTc

Additional relevant MeSH terms:

Anti-Infective Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists
Guanfacine
Moxifloxacin
Therapeutic Uses

ClinicalTrials.gov processed this record on November 09, 2009