Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00672984
First received: May 2, 2008
Last updated: December 22, 2009
Last verified: December 2009
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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:
Drug Information available for:
Guanfacine
Guanfacine hydrochloride
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Shire Development LLC:
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 Development LLC
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 Development LLC:
|
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 May 23, 2013