Guanfacine Immediate-release Electrocardiogram Results (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:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
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:

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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

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
Experimental: Immediate-release Guanfacine HCl	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. Other Name: Tenex
Active Comparator: Moxifloxacin HCl	Drug: moxifloxacin Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6. Other Name: Avelox
Placebo Comparator: Placebo	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

Additional Information:

FDA recall information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00672984 History of Changes
Other Study ID Numbers:	SPD503-112
Study First Received:	May 2, 2008
Results First Received:	September 23, 2009
Last Updated:	December 22, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shire Pharmaceutical Development:

QT/QTc

Additional relevant MeSH terms:

Guanfacine
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012