Trial record 13 of 2105 for:    electrocardiogram

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
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:
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 April 17, 2014