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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868764
• Other study ID #: 392MD/40/C
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2009
• Last updated: October 5, 2009
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Prostrakan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Charles River Clinical Services Edinburgh Ltd	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Prostrakan Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)		0 to 216 hours post-dose	No
Secondary	Safety and tolerability of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)		Up to 23 days post-dose	Yes
Secondary	Patch adhesion and residual granisetron after patch use in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)		0 to 168 hours post-dose	No
Secondary	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)		0 to 216 hours post-dose	No