A Phase 1 interventional study of granisetron in Healthy, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Other
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.
Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment A: Sancuso® patch (Day 1) and placebo IV (Day 3)
Drug: granisetron
Treatment B: placebo patch (Day 1) and granisetron IV (Day 3)
Drug: granisetron
Treatment C: placebo patch (Day 1) and placebo IV (Day 3)
Drug: granisetron
Treatment D: placebo patch (Day 1) and oral moxifloxacin (Day 3).
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
Also known as: Granisetron Transdermal System, Sancuso® patch, Kytril®, Granisetron Injection, IV Placebo (0.9% saline), Placebo patches, Avelox® Oral
Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF).
Time frame: 0 to 120 hours post-dose
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
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
Patch adhesion and residual granisetron after patch use.
Time frame: 0 to 120 hours post-dose
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.