An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron
This study has been completed.
Sponsor:
Prostrakan Pharmaceuticals
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00868764
First received: March 23, 2009
Last updated: October 5, 2009
Last verified: October 2009
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Purpose
This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics |
Drug: granisetron |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron |
Resource links provided by NLM:
Further study details as provided by Prostrakan Pharmaceuticals:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sancuso® patch
Subjects receiving 1 Sancuso® patch worn for 7 days
|
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
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868764
Locations
| United Kingdom | |
| Charles River Clinical Services Edinburgh Ltd | |
| Edinburgh, United Kingdom, EH33 2NE | |
Sponsors and Collaborators
Prostrakan Pharmaceuticals
Investigators
| Principal Investigator: | Stuart J Mair | INC Research |
More Information
No publications provided
| Responsible Party: | Dr Bridget O'Mahony/Clinical Research Manager, Strakan Pharmaceuticals Ltd |
| ClinicalTrials.gov Identifier: | NCT00868764 History of Changes |
| Other Study ID Numbers: | 392MD/40/C |
| Study First Received: | March 23, 2009 |
| Last Updated: | October 5, 2009 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Prostrakan Pharmaceuticals:
|
Effect of age Effect of body fat Granisetron |
Pharmacokinetic profile Sancuso® patch Transdermal |
Additional relevant MeSH terms:
|
Granisetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013