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

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ClinicalTrials.gov Identifier: NCT00868764
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : October 7, 2009
Information provided by:
Prostrakan Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: granisetron Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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
Study Start Date : April 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868764

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United Kingdom
Charles River Clinical Services Edinburgh Ltd
Edinburgh, United Kingdom, EH33 2NE
Sponsors and Collaborators
Prostrakan Pharmaceuticals
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Principal Investigator: Stuart J Mair Syneos Health
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Responsible Party: Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00868764    
Other Study ID Numbers: 392MD/40/C
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009
Keywords provided by Prostrakan Pharmaceuticals:
Effect of age
Effect of body fat
Pharmacokinetic profile
Sancuso® patch
Additional relevant MeSH terms:
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Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action