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

Information source: Prostrakan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: granisetron (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Prostrakan Pharmaceuticals

Official(s) and/or principal investigator(s):
Bridget O'Mahony, PhD, Study Director, Affiliation: Prostrakan Pharmaceuticals

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome: Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF).

Secondary outcome:

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

Relationship of plasma concentration of granisetron versus QTcF, both graphical and mixed effects analyses of plasma concentration of granisetron versus QTcF will be performed

Patch adhesion and residual granisetron after patch use.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Spaulding Clinical Research, LLC, West Bend, Wisconsin 53095, United States
Additional Information

Starting date: May 2009
Last updated: September 24, 2010

Page last updated: August 23, 2015

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