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

NCT00868764 | Completed Phase 1

• 1 other identifier: 392MD/40/C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Keywords

Effect of age; Effect of body fat; Granisetron; Pharmacokinetic profile; Sancuso® patch; Transdermal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Sancuso® patch

EXPERIMENTAL

Subjects receiving 1 Sancuso® patch worn for 7 days

Drug: granisetron

Interventions

granisetron DRUG

3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days

Also known as: Sancuso® patch, Granisetron Transdermal System

Sancuso® patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \-- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Charles River Clinical Services Edinburgh Ltd

Edinburgh, EH33 2NE, United Kingdom

Location

MeSH Terms

Interventions

Granisetron

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stuart J Mair

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 25, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

GB (1)