An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)
研究概览
简要总结
This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Healthy male or female subjects:
- •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
- •- BMI between 20.0 and 29.9 kg/m², inclusive
- •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
排除标准
- •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.
研究组 & 干预措施
Sancuso® patch
Subjects receiving 1 Sancuso® patch worn for 7 days
干预措施: granisetron (Drug)
结局指标
主要结局
Pharmacokinetic profile of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)
时间窗: 0 to 216 hours post-dose
次要结局
- 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)
- 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)
- 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)