CClinicalTrials.gg
CompletedNCT00868764Updated Jul 24, 2024

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

A Phase 1 interventional study of granisetron in Pharmacokinetics, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pharmacokinetics

Keywords

  • Effect of age
  • Effect of body fat
  • Granisetron
  • Pharmacokinetic profile
  • Sancuso® patch
  • Transdermal
03

In context

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Sancuso® patch

    Subjects receiving 1 Sancuso® patch worn for 7 days

    Drug: granisetron

Interventions

  • Druggranisetron

    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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Charles River Clinical Services Edinburgh Ltd
    Edinburgh, EH33 2NE, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00868764
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Mar 25, 2009
Start date
Apr 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jul 24, 2024

Study contacts

Stuart J Mair
principal investigator · Syneos Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion