- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073696
Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects
September 24, 2010 updated by: Prostrakan Pharmaceuticals
A Phase I Study to Evaluate the Effect of External Heat on the Pharmacokinetics of a Transdermal Granisetron Patch in Healthy Subjects
The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Edinburgh
-
Origo Centre, Riccarton, Edinburgh, United Kingdom, EH14 4AP
- Quotient Clinical Limited
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female subjects aged ≥ 18 and ≤ 45 years at screening. Subjects must demonstrate understanding of the purposes and risks of the study and agree to follow the restrictions and schedule of study procedures, as evidenced by voluntary written informed consent (signed and dated) obtained before taking part in any trial-related activities.
Exclusion Criteria:
- Any current or previous disease, disorder, allergy or condition (including recent unexplained weight loss) that could affect the study conduct or laboratory assessments, or that presents undue risk from the study medication or procedures. Hypersensitivity to adhesive plasters or surgical tape.
- Any physical examination or screening investigation result that indicates the subject is unfit for the study.
- Scarring on upper arms, including extensive tattoos making skin reactions unevaluable.
- A positive virology test, urine test for drugs of abuse, or pregnancy test result (females of childbearing potential only).
- Recent use of prescribed or over-the-counter medication that, in the opinion of the Investigator or the Sponsor, will interfere with the study procedures or compromise safety.
- Received an investigational drug within 3 months (90 days) preceding patch application.
- Loss of ≥ 400 mL of blood (e.g. been a blood donor) within the past 3 months.
- Average weekly alcohol consumption of greater than 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before patch application. Subjects may not smoke while confined to the study site. Subjects must not consume alcohol, or xanthine-containing foods or drinks within 48 hours prior to dosing until discharge.
- Lactating female subjects, and female subjects of childbearing potential who are not willing to use an acceptable form of contraception from the screening visit, during the study 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: granisetron IV
|
IV
|
Experimental: granisetron patch
|
patch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied
Time Frame: 0 - 196 hours post dose
|
To assess the effect of locally applied heat on the pharmacokinetic profile of granisetron delivered from the patch.
Subjects will be randomized to receive Treatment A Sancuso patch ONLY and Treatment B, Sancuso PLUS Cura-Heat pad.
Sancuso will be worn by the subjects for 5 days continuously.
The Cura-Heat pad will be applied over the patch for 4.5 hours on each of the 5 days.
During these 5 days PK sampling is planned to measure the initial release of granisetron from the patch and cover the predicted maximum observed concentrations with or without the Cura-Heat pad in place.
|
0 - 196 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability assessment
Time Frame: Up to 23 days post dose
|
Safety and tolerability will be assessed by collection of adverse events, safety laboratory assessments, record of vital signs, conduct of physical examination and 12 lead ECG.
In addition skin reaction at the patch and Cura-Heat pad application sites will be monitored.
|
Up to 23 days post dose
|
residual granisetron after patch use in healthy subjects
Time Frame: 120 hours post dose
|
• Residual granisetron after patch use and the calculation of in-vitro flux will be measured.
All used patches will be returned to the manufacturer who will measure the amount of remaining granisetron in the patch and then the in-vitro flux will be calculated as follows: Amount delivered(assay amount-residual)/ number of days the patch was applied to the skin
|
120 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart J Mair, Quotient Clinical Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 22, 2010
First Posted (Estimate)
February 23, 2010
Study Record Updates
Last Update Posted (Estimate)
September 27, 2010
Last Update Submitted That Met QC Criteria
September 24, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 392MD/43/C
- 2009-017036-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on granisetron IV
-
Clinica Universidad de Navarra, Universidad de...Completed
-
Kyowa Kirin Pharmaceutical Development LtdWithdrawnChemotherapy Induced Nausea and Vomiting
-
Kyowa Kirin Pharmaceutical Development LtdCompletedChemotherapy Induced Nausea and VomitingUnited States
-
Kyowa Kirin Pharmaceutical Development LtdWithdrawnChemotherapy Induced Nausea and Vomiting
-
Prostrakan PharmaceuticalsCompleted
-
Prostrakan PharmaceuticalsCompleted
-
Alexza Pharmaceuticals, Inc.CelerionCompleted
-
Maxinase Life Sciences Ltd.Tri-Service General HospitalCompleted
-
Prostrakan PharmaceuticalsCompletedPharmacokineticsUnited Kingdom
-
Fudan UniversityRecruitingChemotherapy-induced Nausea and Vomiting (CINV)China