HealthyPhase 1NCT01073696
Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects
A Phase 1 study testing granisetron IV and granisetron patch in people with Healthy, run by Kyowa Kirin Co., Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- granisetron IV and granisetron patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- granisetron IV, granisetron patch
- Keywords
- Sancuso, granisetron, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
granisetron IVDrug
IV
granisetron patchDrug
patch
| Study group | Role | What they receive |
|---|---|---|
| granisetron IV | Active comparator | Not described Receives: Drug: granisetron IV |
| granisetron patch | Experimental | Not described Receives: Drug: granisetron patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied
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.
Measured: 0 - 196 hours post dose
Secondary outcomes (2)
Safety and tolerability assessment
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.
Measured: Up to 23 days post dose
residual granisetron after patch use in healthy subjects
- 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
Measured: 120 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart J Mair, Principal investigator, Quotient Clinical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073696
- Sponsor's protocol ID
- 392MD/43/C
- Other IDs
- 2009-017036-40, 2009
- Status last verified
- Jun 2024
- First submitted
- 16 Feb 2010
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Effect of External Heat on the Pharmacokinetics of a Transdermal Granisetron Patch in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01073696
- Acronym / sponsor ID
- 392MD/43/C
- Conditions
- Healthy
- Keywords
- Sancuso, granisetron, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| granisetron IV | Active comparator | Drug: granisetron IV |
| granisetron patch | Experimental | Drug: granisetron patch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| granisetron IVIV | Drug | granisetron IV |
| granisetron patchpatch | Drug | granisetron patch |
Primary outcome
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.
2 secondary outcomes
Safety and tolerability assessment
Time frame: Up to 23 days post dose
residual granisetron after patch use in healthy subjects
Time frame: 120 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart J Mair principal investigator
Quotient Clinical Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing granisetron IV and granisetron patch in people with Healthy, run by Kyowa Kirin Co., Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied (time frame: 0 - 196 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.