Status:
COMPLETED
Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects.
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00890565
Start Date
May 1 2009
End Date
September 1 2009
Last Update
June 17 2024
Active Locations (1)
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1
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095