A Phase 1 interventional study of granisetron in Pharmacokinetics, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Other
This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.
Sancuso® (granisetron transdermal system [TDS] or patch) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008, indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days' duration.
While in vivo pharmacokinetic studies with Sancuso® in healthy adults and in subjects receiving chemotherapy have been conducted, there are limited data from subjects who have altered skin integrity due to advanced age or poor nutritional status related to chronic illness. In addition, available data suggest that granisetron is delivered into subcutaneous fat and is released from that compartment over time. It is possible that individuals with varying nutritional status and resultant differences in subcutaneous fat would have differences in pharmacokinetics.
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.
-- Healthy male or female subjects:
Part I
Part II -- Aged between 18 and 60 years, inclusive, at screening
Part I
-- BMI between 20.0 and 29.9 kg/m², inclusive
Part II
Exclusion Criteria:
Subjects receiving 1 Sancuso® patch worn for 7 days
Drug: granisetron
3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days
Also known as: Sancuso® patch, Granisetron Transdermal System
Pharmacokinetic profile of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)
Time frame: 0 to 216 hours post-dose
Safety and tolerability of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)
Time frame: Up to 23 days post-dose
Patch adhesion and residual granisetron after patch use in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)
Time frame: 0 to 168 hours post-dose
PK profile of the granisetron patch in elderly subjects vs younger subjects (Part 1) and PK profile of the granisetron patch in underweight and obese subjects vs in subjects whose body mass index (BMI) is within the normal range (Part 2)
Time frame: 0 to 216 hours post-dose
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kyowa Kirin Co., Ltd.