HealthyPhase 1NCT00890565
Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)
A Phase 1 study testing granisetron in people with Healthy, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
Trial summary
This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- granisetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- Aged between 18 and 50 years, inclusive, at screening
- BMI between 18.0 and 32.0 kg/m², inclusive
Who cannot join
- History of drug abuse
- Known hypersensitivity to granisetron, moxifloxacin, or related compounds, such as ciprofloxacin and levofloxacin
- Sustained supine systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg at Screening or baseline
- Pulse rate at rest of < 45 bpm or > 100 bpm
- Abnormal Screening ECG indicating a second- or third degree AV block, or one or more of the following: QRS >120 milliseconds (ms); QTcF > 430 (males) or 450 (females) ms; PR interval >240 ms; any rhythm, other than sinus rhythm, interpreted to be clinically significant by the Investigator
- Known history of long-QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, chest pain or dyspnea on exertion
- Electrolyte disturbances (such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, hypocalcemia, or hypophosphatemia), idiopathic cardiomyopathy, unexplained syncope, hypertrophic cardiomyopathy, or sudden unexplained death at a young age (< 40 years) in a first-degree relative.
- Has used any medications or consumed any foods contraindicated in the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Single-Blind, Randomized, Parallel Trial to Define the ECG Effects of Sancuso® (Granisetron Transdermal System) Compared to Placebo and Moxifloxacin in Healthy Men and Women
This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects.
Read the detailed description
Granisetron is a well tested and established 5-HT3 receptor antagonist used in both oral and intravenous (IV) forms. A transdermal form of granisetron (Sancuso®) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008.
Many of the 5-HT3 antagonists were developed and approved before the adoption of the International Conference on Harmonisation (ICH) E14 standard on QTc and cardiac testing. The association of non-cardiac medicinal products with the potential to prolong the QT interval and induce torsades des pointes (TdP) has significant implications for the future development of medicinal products.
- Conditions
- Healthy
- Being tested
- granisetron
- Keywords
- Electrocardiogram, Effect on electrocardiogram, Granisetron, Moxifloxacin, Pharmacokinetic profile, Sancuso® patch, Transdermal
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
Treatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Sancuso® patch | Experimental | Treatment A: Sancuso® patch (Day 1) and placebo IV (Day 3) Receives: Drug: granisetron |
| Treatment B: IV Granisetron 10 mcg/kg | Experimental | Treatment B: placebo patch (Day 1) and granisetron IV (Day 3) Receives: Drug: granisetron |
| Treatment C: Matching placebo patch | Placebo comparator | Treatment C: placebo patch (Day 1) and placebo IV (Day 3) Receives: Drug: granisetron |
| Treatment D: Oral Moxifloxacin 400 mg | Active comparator | Treatment D: placebo patch (Day 1) and oral moxifloxacin (Day 3). Receives: Drug: granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF).
Measured: 0 to 120 hours post-dose
Secondary outcomes (3)
QTc with Bazett correction (QTcB), heart rate, PR interval, QRS interval, uncorrected QT interval, change in ECG morphological patterns and correlation between the QTcF change from baseline and plasma granisetron concentrations
Measured: 0 to 120 hours post-dose
Relationship of plasma concentration of granisetron versus QTcF, both graphical and mixed effects analyses of plasma concentration of granisetron versus QTcF will be performed
Measured: 0 to 120 hours post-dose
Patch adhesion and residual granisetron after patch use.
Measured: 0 to 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 posted30 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2009
- Study completionSep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget O'Mahony, PhD, Study director, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890565
- Sponsor's protocol ID
- 392MD/39/C
- Status last verified
- Jun 2024
- First submitted
- 29 Apr 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 Single-Blind, Randomized, Parallel Trial to Define the ECG Effects of Sancuso® (Granisetron Transdermal System) Compared to Placebo and Moxifloxacin in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT00890565
- Acronym / sponsor ID
- 392MD/39/C
- Conditions
- Healthy
- Keywords
- Electrocardiogram, Effect on electrocardiogram, Granisetron, Moxifloxacin, Pharmacokinetic profile, Sancuso® patch, Transdermal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 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 aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects.
Detailed description
Granisetron is a well tested and established 5-HT3 receptor antagonist used in both oral and intravenous (IV) forms. A transdermal form of granisetron (Sancuso®) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008.
Many of the 5-HT3 antagonists were developed and approved before the adoption of the International Conference on Harmonisation (ICH) E14 standard on QTc and cardiac testing. The association of non-cardiac medicinal products with the potential to prolong the QT interval and induce torsades des pointes (TdP) has significant implications for the future development of medicinal products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Sancuso® patch | Experimental | Drug: granisetronTreatment A: Sancuso® patch (Day 1) and placebo IV (Day 3) |
| Treatment B: IV Granisetron 10 mcg/kg | Experimental | Drug: granisetronTreatment B: placebo patch (Day 1) and granisetron IV (Day 3) |
| Treatment C: Matching placebo patch | Placebo comparator | Drug: granisetronTreatment C: placebo patch (Day 1) and placebo IV (Day 3) |
| Treatment D: Oral Moxifloxacin 400 mg | Active comparator | Drug: granisetronTreatment D: placebo patch (Day 1) and oral moxifloxacin (Day 3). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects
- Aged between 18 and 50 years, inclusive, at screening
- BMI between 18.0 and 32.0 kg/m², inclusive
Key exclusion criteria (8 listed)
- History of drug abuse
- Known hypersensitivity to granisetron, moxifloxacin, or related compounds, such as ciprofloxacin and levofloxacin
- Sustained supine systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg at Screening or baseline
- Pulse rate at rest of < 45 bpm or > 100 bpm
- Abnormal Screening ECG indicating a second- or third degree AV block, or one or more of the following: QRS >120 milliseconds (ms); QTcF > 430 (males) or 450 (females) ms; PR interval >240 ms; any rhythm, other than sinus rhythm, interpreted to be clinically significant by the Investigator
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 InjectionTreatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3 | Drug | Treatment A: Sancuso® patch, Treatment B: IV Granisetron 10 mcg/kg, Treatment C: Matching placebo patch, Treatment D: Oral Moxifloxacin 400 mg |
Primary outcome
Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF).
Time frame: 0 to 120 hours post-dose
3 secondary outcomes
QTc with Bazett correction (QTcB), heart rate, PR interval, QRS interval, uncorrected QT interval, change in ECG morphological patterns and correlation between the QTcF change from baseline and plasma granisetron concentrations
Time frame: 0 to 120 hours post-dose
Relationship of plasma concentration of granisetron versus QTcF, both graphical and mixed effects analyses of plasma concentration of granisetron versus QTcF will be performed
Time frame: 0 to 120 hours post-dose
Patch adhesion and residual granisetron after patch use.
Time frame: 0 to 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.
Bridget O'Mahony, PhD study director
Kyowa Kirin Co., Ltd.
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 States.
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 3 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 States. 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. Some participants in this study may receive a placebo. 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?
Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF). (time frame: 0 to 120 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.