Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00672984
First received: May 2, 2008
Last updated: December 22, 2009
Last verified: December 2009
  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 1

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:


Further study details as provided by Shire:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Robert S. Kahn, MD Charles River Clinical Services Northwest Inc.
  More Information

Additional Information:
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:
QT/QTc

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Guanfacine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 29, 2014