NCT00868764

An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.

Detailed description

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-03-25
• Last updated: 2024-07-24

Locations

1 site across 1 country: United Kingdom