PK, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and IV Granisetron
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Study to Assess the Pharmacokinetics, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects|
- Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch [ Time Frame: 0 to 336 hours post-dose ] [ Designated as safety issue: No ]
- Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch [ Time Frame: Up to 28 days post-dose ] [ Designated as safety issue: No ]
- Patch adhesion and residual granisetron after patch [ Time Frame: 0 to 336 hours post-dose ] [ Designated as safety issue: No ]
- Pharmacokinetic profile of repeated Sancuso® patch application [ Time Frame: 0 to 336 hours post-dose ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: Sancuso® patch/IV granisetron
Subjects will receive 1 Sancuso® patch worn for 7 days (168 hours). Immediately after the patch has been applied on Day 1, IV granisetron will be administered over 30 seconds. Following patch removal at 168 hours, a new patch will be immediately applied to the opposite arm and will remain in place for a further 7 days (168 to 336 hours).
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.
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.
|Charles River Clinical Services Edinburgh Ltd|
|Edinburgh, United Kingdom, EH33 2NE|
|Principal Investigator:||Stuart J Mair||INC Research|