HealthyPhase 1NCT00873197
PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron
A Phase 1 study testing granisetron in people with Healthy, run by Kyowa Kirin Co., Ltd. at 1 site in United Kingdom.
Trial summary
This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- granisetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to May 2009
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female Caucasian subjects
- Aged between 18 and 70 years, inclusive, at screening
- BMI between 20.0 and 29.9 kg/m², inclusive.
- Must demonstrate understanding of the purposes and risks of the study
- Must agree to follow the restrictions and schedule of study procedures
Who cannot join
- 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 the study.
- Scarring on upper arms.
- Positive virology, urine drugs of abuse or pregnancy test result (females of childbearing potential only).
- Recent use of prescribed or over the counter medication.
- Participation in any clinical study or loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 60 days.
- 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 the first study drug administration.
- Lactating female subjects and female subjects of childbearing potential who are not willing to use an acceptable form of contraception during and for 90 days after the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charles River Clinical Services Edinburgh Ltd
Edinburgh, EH33 2NE
About this study
Official title: A Study to Assess the Pharmacokinetics, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects
This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.
Read the detailed description
Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose of granisetron to provide prophylaxis while the granisetron from the patch reaches a therapeutic plasma concentration.
Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses; however, several regimens are administered over more than 5 days and others are given at frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple transdermal dosing offers useful information for clinicians who treat patients with the latter types of regimens.
- Conditions
- Healthy
- Being tested
- granisetron
- Keywords
- Co-administration of transdermal and intravenous granisetron, Granisetron, Healthy subjects, Intravenous, Pharmacokinetic profile, Sancuso® patch, Transdermal, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
granisetronDrug
Also called Granisetron Transdermal System, Sancuso® patch, Kytril®, Granisetron Injection
Sancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours).
Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only.
| Study group | Role | What they receive |
|---|---|---|
| Sancuso® patch/IV granisetron | Experimental | Subjects will receive 1 Sancuso® patch worn for 7 days (168 hours). Immediately after the patch has been applied on Day 1, IV granisetron will be administered over 30 seconds. Following patch removal at 168 hours, a new patch will be immediately applied to the opposite arm and will remain in place for a further 7 days (168 to 336 hours). Receives: Drug: granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch
Measured: 0 to 336 hours post-dose
Secondary outcomes (3)
Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch
Measured: Up to 28 days post-dose
Patch adhesion and residual granisetron after patch
Measured: 0 to 336 hours post-dose
Pharmacokinetic profile of repeated Sancuso® patch application
Measured: 0 to 336 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 posted1 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 2009
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873197
- Sponsor's protocol ID
- 392MD/41/C
- Status last verified
- Jun 2024
- First submitted
- 31 Mar 2009
- 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 Study to Assess the Pharmacokinetics, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and Intravenous Granisetron in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00873197
- Acronym / sponsor ID
- 392MD/41/C
- Conditions
- Healthy
- Keywords
- Co-administration of transdermal and intravenous granisetron, Granisetron, Healthy subjects, Intravenous, Pharmacokinetic profile, Sancuso® patch, Transdermal, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Apr 2009 (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.
This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.
Detailed description
Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-48 hours pre-chemotherapy), clinicians might use a single IV dose of granisetron to provide prophylaxis while the granisetron from the patch reaches a therapeutic plasma concentration.
Most chemotherapeutics are dosed in a single day, with a 2- or 3-week interval between doses; however, several regimens are administered over more than 5 days and others are given at frequencies (e.g. every 5 days). Thus, more than one patch may be required to provide continuous antiemetic prophylaxis. Characterisation of the pharmacokinetics of multiple transdermal dosing offers useful information for clinicians who treat patients with the latter types of regimens.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sancuso® patch/IV granisetron | Experimental | Drug: granisetronSubjects will receive 1 Sancuso® patch worn for 7 days (168 hours). Immediately after the patch has been applied on Day 1, IV granisetron will be administered over 30 seconds. Following patch removal at 168 hours, a new patch will be immediately applied to the opposite arm and will remain in place for a further 7 days (168 to 336 hours). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female Caucasian subjects
- Aged between 18 and 70 years, inclusive, at screening
- BMI between 20.0 and 29.9 kg/m², inclusive.
- Must demonstrate understanding of the purposes and risks of the study
- Must agree to follow the restrictions and schedule of study procedures
Key exclusion criteria (8 listed)
- 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 the study.
- Scarring on upper arms.
- Positive virology, urine drugs of abuse or pregnancy test result (females of childbearing potential only).
- Recent use of prescribed or over the counter medication.
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 |
|---|---|---|
| granisetronAlso: Granisetron Transdermal System, Sancuso® patch, Kytril®, Granisetron InjectionSancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours). Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only. | Drug | Sancuso® patch/IV granisetron |
Primary outcome
Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patch
Time frame: 0 to 336 hours post-dose
3 secondary outcomes
Safety and tolerability of the coadministration of IV granisetron and the Sancuso® patch
Time frame: Up to 28 days post-dose
Patch adhesion and residual granisetron after patch
Time frame: 0 to 336 hours post-dose
Pharmacokinetic profile of repeated Sancuso® patch application
Time frame: 0 to 336 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
Syneos Health
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 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 5 inclusion and 8 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 co-administration of IV granisetron and the Sancuso® patch (time frame: 0 to 336 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.