Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects
This study has been completed.
Information provided by:
First received: February 16, 2010
Last updated: September 24, 2010
Last verified: February 2010
The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Evaluate the Effect of External Heat on the Pharmacokinetics of a Transdermal Granisetron Patch in Healthy Subjects|
Resource links provided by NLM:
Further study details as provided by Prostrakan Pharmaceuticals:
Primary Outcome Measures:
- Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied [ Time Frame: 0 - 196 hours post dose ] [ Designated as safety issue: No ]To assess the effect of locally applied heat on the pharmacokinetic profile of granisetron delivered from the patch. Subjects will be randomized to receive Treatment A Sancuso patch ONLY and Treatment B, Sancuso PLUS Cura-Heat pad. Sancuso will be worn by the subjects for 5 days continuously. The Cura-Heat pad will be applied over the patch for 4.5 hours on each of the 5 days. During these 5 days PK sampling is planned to measure the initial release of granisetron from the patch and cover the predicted maximum observed concentrations with or without the Cura-Heat pad in place.
Secondary Outcome Measures:
- Safety and tolerability assessment [ Time Frame: Up to 23 days post dose ] [ Designated as safety issue: Yes ]Safety and tolerability will be assessed by collection of adverse events, safety laboratory assessments, record of vital signs, conduct of physical examination and 12 lead ECG. In addition skin reaction at the patch and Cura-Heat pad application sites will be monitored.
- residual granisetron after patch use in healthy subjects [ Time Frame: 120 hours post dose ] [ Designated as safety issue: No ]• Residual granisetron after patch use and the calculation of in-vitro flux will be measured. All used patches will be returned to the manufacturer who will measure the amount of remaining granisetron in the patch and then the in-vitro flux will be calculated as follows: Amount delivered(assay amount-residual)/ number of days the patch was applied to the skin
|Study Start Date:||March 2010|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: granisetron IV||
Drug: granisetron IV
|Experimental: granisetron patch||
Drug: granisetron patch
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073696
|Quotient Clinical Limited|
|Origo Centre, Riccarton, Edinburgh, United Kingdom, EH14 4AP|
Sponsors and Collaborators
|Principal Investigator:||Stuart J Mair||Quotient Clinical Limited|