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Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)

This study has been completed.
Sponsor:
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00890565
First received: April 29, 2009
Last updated: September 24, 2010
Last verified: October 2009

April 29, 2009
September 24, 2010
May 2009
August 2009   (final data collection date for primary outcome measure)
Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF). [ Time Frame: 0 to 120 hours post-dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00890565 on ClinicalTrials.gov Archive Site
  • QTc with Bazett correction (QTcB), heart rate, PR interval, QRS interval, uncorrected QT interval, change in ECG morphological patterns and correlation between the QTcF change from baseline and plasma granisetron concentrations [ Time Frame: 0 to 120 hours post-dose ] [ Designated as safety issue: Yes ]
  • Relationship of plasma concentration of granisetron versus QTcF, both graphical and mixed effects analyses of plasma concentration of granisetron versus QTcF will be performed [ Time Frame: 0 to 120 hours post-dose ] [ Designated as safety issue: Yes ]
  • Patch adhesion and residual granisetron after patch use. [ Time Frame: 0 to 120 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)
A Single-Blind, Randomized, Parallel Trial to Define the ECG Effects of Sancuso® (Granisetron Transdermal System) Compared to Placebo and Moxifloxacin in Healthy Men and Women

This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects.

Granisetron is a well tested and established 5-HT3 receptor antagonist used in both oral and intravenous (IV) forms. A transdermal form of granisetron (Sancuso®) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008.

Many of the 5-HT3 antagonists were developed and approved before the adoption of the International Conference on Harmonisation (ICH) E14 standard on QTc and cardiac testing. The association of non-cardiac medicinal products with the potential to prolong the QT interval and induce torsades des pointes (TdP) has significant implications for the future development of medicinal products.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Healthy
Drug: granisetron
Treatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3
Other Names:
  • Granisetron Transdermal System
  • Sancuso® patch
  • Kytril®
  • Granisetron Injection
  • IV Placebo (0.9% saline)
  • Placebo patches
  • Avelox® Oral
  • Experimental: Treatment A: Sancuso® patch
    Treatment A: Sancuso® patch (Day 1) and placebo IV (Day 3)
    Intervention: Drug: granisetron
  • Experimental: Treatment B: IV Granisetron 10 mcg/kg
    Treatment B: placebo patch (Day 1) and granisetron IV (Day 3)
    Intervention: Drug: granisetron
  • Placebo Comparator: Treatment C: Matching placebo patch
    Treatment C: placebo patch (Day 1) and placebo IV (Day 3)
    Intervention: Drug: granisetron
  • Active Comparator: Treatment D: Oral Moxifloxacin 400 mg
    Treatment D: placebo patch (Day 1) and oral moxifloxacin (Day 3).
    Intervention: Drug: granisetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
September 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects
  • Aged between 18 and 50 years, inclusive, at screening
  • BMI between 18.0 and 32.0 kg/m², inclusive

Exclusion Criteria:

  • History of drug abuse
  • Known hypersensitivity to granisetron, moxifloxacin, or related compounds, such as ciprofloxacin and levofloxacin
  • Sustained supine systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg at Screening or baseline
  • Pulse rate at rest of < 45 bpm or > 100 bpm
  • Abnormal Screening ECG indicating a second- or third degree AV block, or one or more of the following: QRS >120 milliseconds (ms); QTcF > 430 (males) or 450 (females) ms; PR interval >240 ms; any rhythm, other than sinus rhythm, interpreted to be clinically significant by the Investigator
  • Known history of long-QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, chest pain or dyspnea on exertion
  • Electrolyte disturbances (such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, hypocalcemia, or hypophosphatemia), idiopathic cardiomyopathy, unexplained syncope, hypertrophic cardiomyopathy, or sudden unexplained death at a young age (< 40 years) in a first-degree relative.
  • Has used any medications or consumed any foods contraindicated in the protocol.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00890565
392MD/39/C
No
Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd
Prostrakan Pharmaceuticals
Not Provided
Study Director: Bridget O'Mahony, PhD Prostrakan Pharmaceuticals
Prostrakan Pharmaceuticals
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP