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

This study has been completed.
Information provided by:
Prostrakan Pharmaceuticals Identifier:
First received: March 23, 2009
Last updated: October 5, 2009
Last verified: October 2009
This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.

Condition Intervention Phase
Pharmacokinetics Drug: granisetron Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron

Resource links provided by NLM:

Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sancuso® patch
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
Other Names:
  • Sancuso® patch
  • Granisetron Transdermal System

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

-- Healthy male or female subjects:

Part I

  • Aged ≥ 65 years at screening
  • Control group: aged ≥ 18 to 45 years at screening

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

  • Underweight (BMI < 18.5 kg/m²) or obese (BMI between 30.0 and 39.9 kg/m², inclusive)
  • Control group: BMI between 20.0 and 24.9 kg/m², inclusive

Exclusion Criteria:

  • Current or previous disease, disorder, allergy or condition that could affect study conduct or laboratory assessments, or that presents undue risk from study medication or procedures.
  • Physical examination or screening investigation result that indicates subject is unfit for study.
  • Scarring on upper arms.
  • Positive virology, urine drugs of abuse or pregnancy test result (female subjects of childbearing potential only).
  • Recent use of prescribed or over-the-counter medication.
  • Received an investigational drug within 3 months (90 days) prior to patch application.
  • Loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 3 months.
  • Average weekly alcohol consumption > 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before patch application.
  • Lactating female subjects and female subjects of childbearing potential not willing to use an acceptable form of contraception during and for 90 days after the study.
  • Employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members of the employees or the investigator.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00868764

United Kingdom
Charles River Clinical Services Edinburgh Ltd
Edinburgh, United Kingdom, EH33 2NE
Sponsors and Collaborators
Prostrakan Pharmaceuticals
Principal Investigator: Stuart J Mair INC Research
  More Information

Responsible Party: Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd Identifier: NCT00868764     History of Changes
Other Study ID Numbers: 392MD/40/C
Study First Received: March 23, 2009
Last Updated: October 5, 2009

Keywords provided by Prostrakan Pharmaceuticals:
Effect of age
Effect of body fat
Pharmacokinetic profile
Sancuso® patch

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017