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

This study has been completed.
Sponsor:
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00868764
First received: March 23, 2009
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868764

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

No publications provided

Responsible Party: Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00868764     History of Changes
Other Study ID Numbers: 392MD/40/C
Study First Received: March 23, 2009
Last Updated: October 5, 2009
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Granisetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014