Status:
COMPLETED
An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.
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 vomit...
Eligibility Criteria
Inclusion
- \-- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00868764
Start Date
April 1 2009
End Date
September 1 2009
Last Update
July 24 2024
Active Locations (1)
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1
Charles River Clinical Services Edinburgh Ltd
Edinburgh, United Kingdom, EH33 2NE