NCT00873197

PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

A Study to Assess the Pharmacokinetics, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.

Detailed description

Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose of granisetron to provide prophylaxis while the granisetron from the patch reaches a therapeutic plasma concentration. Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses; however, several regimens are administered over more than 5 days and others are given at frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple transdermal dosing offers useful information for clinicians who treat patients with the latter types of regimens.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	granisetron	Sancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours). Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-04-01
• Last updated: 2024-06-17

Locations

1 site across 1 country: United Kingdom