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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00890565

Run by

Kyowa Kirin Co., Ltd.

People needed

240

Starts

2009-05-01

Expected to finish

2009-09-01

Last updated by the study team

2024-06-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Spaulding Clinical Research, LLC — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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