Healthy VolunteersPhase 1NCT05027646
Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.
A Phase 1 study testing Sancuso - Part 1 and Sancuso - Part 2 in people with Healthy Volunteers, run by Kyowa Kirin, Inc. at 1 site in United States.
Trial summary
The study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sancuso - Part 1 and Sancuso - Part 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 19 Jan 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 to 55 years, inclusive
- BMI 18 to 30 kg/m2
- Healthy volunteers, health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results and physical examination.
- Agrees to comply with all protocol requirements.
- Able to provide written and voluntary informed consent.
- Female participants of childbearing potential have a negative pregnancy test and agree to adhere to an acceptable methods of birth control.
- Male participants with female partners of childbearing potential agree to acceptable methods of birth control.
Who cannot join
- Participant to be excluded if,
- Presents with baseline systolic blood pressure >140 mm Hg and diastolic blood pressure >90 mm Hg.
- Any clinically significant ECG finding or QTcF interval >450 msec for males and >470 msec for females.
- A history of sensitivity to granisetron or other components of the transdermal patch.
- Pregnant or breastfeeding.
- Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, as determined by the investigator.
Show all 27Show fewer
- Participants with following pre-existing liver functioning test elevations will be excluded: alanine aminotransferase or aspartate aminotransferase elevation >2 × ULN, and/or bilirubin >2 × ULN
- Acute or chronic renal or hepatic impairment, that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, as determined by the investigator.
- Acute or chronic psychiatric condition, including, but not limited to compulsive-depressive disorders, anxiety, and/or sleep disorders that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results.
- A history of coronary heart disease, arterial or pulmonary hypertension, supraventricular or ventricular tachycardias, or other arrhythmias or heart rhythm and conduction disorders.
- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
- If used any prescription (excluding hormonal birth control) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first application of the transdermal patch.
- If used 5-HT3 receptor antagonists and other serotonergic drugs (eg, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and IV methylene blue) within 14 days before the first application of the transdermal patch.
- If used antihistamines within 72 hours prior to patch application or systemic or topical corticosteroids within 3 weeks before the first application of the transdermal patch.
- Present with a dermatological disorder at any relevant patch application site that precludes proper placement or may interfere with adhesion, site assessment, or potentially affect drug absorption.
- Has allergies or other contraindications to transdermal systems or patch adhesives or to medical adhesive tape, adhesive dressings, or other skin patches.
- If not willing to allow hair to be removed or clipped at the proposed patch application sites that may prevent proper placement of the patch.
- If presents with and has oily skin or any skin problems such as being damaged (cut or scraped) or irritated (redness or a rash) at the application sites.
- If consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or alcohol-, caffeine-, or xanthine containing products within 48 hours before the first application
- The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months before the first application of the transdermal patch.
- If has a history of alcohol abuse or drug addiction within a year.
- If presents with a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking).
- If involved in strenuous activity or contact sports within 24 hours before the first application and during the study.
- If donated blood or blood products >450 mL within 30 days before the first application.
- If has a history of relevant drug and/or food or significant food allergy that could preclude a standard diet in the CRU.
- If received study drug in another investigational study within 30 days of the first application.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Replicate Treatment, 2-Part, Crossover Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches Manufactured at Different Sites.
The study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry. Bioequivalence will be based on the Cmax and AUC to determine the peak and total drug exposure, respectively.
Read the detailed description
This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish bioequivalence (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches manufactured at 2 different sites (Sancuso [test] and Sancuso [reference]).
Each part of the study will consist of a screening period, check-in days, treatment periods, washout period (Part 1 only), and an end-of-study visit. The duration of subject participation, excluding screening, for Part 1 is approximately 39 days and for Part 2 is approximately 17 days.
- Conditions
- Healthy Volunteers
- Being tested
- Sancuso - Part 1, Sancuso - Part 2
- Keywords
- Patch, Nausea, Anti-emetic, Granisetron
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sancuso - Part 1Drug
Also called Granisetron Transdermal Patch
Part 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
Sancuso - Part 2Drug
Also called Granisetron Transdermal Patch
Part 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Bioequivalence | Experimental | Bioequivalence will be measured in approximately 42 healthy male and female subjects at a single center in the US to achieve at least 33 completers. Receives: Drug: Sancuso - Part 1 |
| Part 2 - Adhesion | Experimental | Adhesion will be measured in approximately 90 healthy male and female subjects are planned to be enrolled at a single center in the US. Receives: Drug: Sancuso - Part 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve AUC (0-t)
AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule
Measured: 6 months
Area under the plasma concentration versus time curve AUC (0-inf)
AUC from time 0 extrapolated to infinity, calculated as (AUC 0-t + [Clast/λz]) where Clast is the last measurable plasma concentration
Measured: 6 months
Peak Plasma Concentration (Cmax)
Maximum concentration after dosing
Measured: 6 months
Maximum concentration (Tmax)
Time to reach the maximum plasma concentration after dosing (Tmax)
Measured: 6 months
T1/2
Terminal phase half-life
Measured: 6 months
CL/F
Total clearance after dosing
Measured: 6 months
Vz/F
Apparent volume of distribution during the terminal phase, calculated as (CL/F)λz
Measured: 6 months
Mean adhesion score (FDA scale)
Adhesion of the patch to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is: 0 = ≥ 90% adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin), 3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely off the skin). Adhesion is assessed daily when patches are insitu. The mean adhesion score will be derived from its individual adhesion scores at each assessment time point, averaged across all the equally spaced time points (except baseline timepoint). Difference in mean adhesion score between test and reference transdermal patches will be compared using a mixed-model analysis of variance.
Measured: 6 months
Secondary outcomes (2)
Number of subjects with treatment related adverse events will be as assessed as mild, moderate or severe and will be summarized descriptively and presented as frequency and percentage.
Actual values and changes from baseline for clinical laboratory test results, vital sign measurements and 12-lead ECG results will be summarized by test and reference patches at each time point using descriptive statistics (number of subjects, mean, SD, median, minimum and maximum)
Measured: 6 Months
Adhesion performance score (FDA Scale)
Adhesion of the patch to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is: 0 = ≥ 90% adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin), 3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely off the skin). Adhesion is assessed daily when patches are insitu. Proportion of subjects with adhesion performance score of interest will be compared between the test and reference transdermal patches. Time to mean adhesion score more than or equal to 2 will be investigated graphically if data warrant.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start6 Jul 2021
- Primary completion22 Dec 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish BE (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches.
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027646
- Sponsor's protocol ID
- 392MD/48/C
- Status last verified
- Jun 2024
- First submitted
- 9 Aug 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations (DHHS 2014). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). March 2014
Guidance for Industry: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs (DHHS 2018). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2018
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Replicate Treatment, 2-Part, Crossover Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches Manufactured at Different Sites.
- ClinicalTrials.gov ID
- NCT05027646
- Acronym / sponsor ID
- 392MD/48/C
- Conditions
- Healthy Volunteers
- Keywords
- Patch, Nausea, Anti-emetic, Granisetron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- 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 study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry. Bioequivalence will be based on the Cmax and AUC to determine the peak and total drug exposure, respectively.
Detailed description
This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish bioequivalence (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches manufactured at 2 different sites (Sancuso [test] and Sancuso [reference]).
Each part of the study will consist of a screening period, check-in days, treatment periods, washout period (Part 1 only), and an end-of-study visit. The duration of subject participation, excluding screening, for Part 1 is approximately 39 days and for Part 2 is approximately 17 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish BE (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches.
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Bioequivalence | Experimental | Drug: Sancuso - Part 1Bioequivalence will be measured in approximately 42 healthy male and female subjects at a single center in the US to achieve at least 33 completers. |
| Part 2 - Adhesion | Experimental | Drug: Sancuso - Part 2Adhesion will be measured in approximately 90 healthy male and female subjects are planned to be enrolled at a single center in the US. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female 18 to 55 years, inclusive
- BMI 18 to 30 kg/m2
- Healthy volunteers, health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results and physical examination.
- Agrees to comply with all protocol requirements.
- Able to provide written and voluntary informed consent.
Key exclusion criteria (27 listed)
- Participant to be excluded if,
- Presents with baseline systolic blood pressure >140 mm Hg and diastolic blood pressure >90 mm Hg.
- Any clinically significant ECG finding or QTcF interval >450 msec for males and >470 msec for females.
- A history of sensitivity to granisetron or other components of the transdermal patch.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| Sancuso - Part 1Also: Granisetron Transdermal PatchPart 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors. | Drug | Part 1 - Bioequivalence |
| Sancuso - Part 2Also: Granisetron Transdermal PatchPart 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors. | Drug | Part 2 - Adhesion |
Primary outcome
Area under the plasma concentration versus time curve AUC (0-t)
Time frame: 6 months
AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule
Area under the plasma concentration versus time curve AUC (0-inf)
Time frame: 6 months
AUC from time 0 extrapolated to infinity, calculated as (AUC 0-t + [Clast/λz]) where Clast is the last measurable plasma concentration
Peak Plasma Concentration (Cmax)
Time frame: 6 months
Maximum concentration after dosing
Maximum concentration (Tmax)
Time frame: 6 months
Time to reach the maximum plasma concentration after dosing (Tmax)
T1/2
Time frame: 6 months
Terminal phase half-life
CL/F
Time frame: 6 months
Total clearance after dosing
Vz/F
Time frame: 6 months
Apparent volume of distribution during the terminal phase, calculated as (CL/F)λz
Mean adhesion score (FDA scale)
Time frame: 6 months
Adhesion of the patch to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is: 0 = ≥ 90% adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% adhered (less than half of the patch lifting off the skin), 3 = > 0% to < 50% adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely off the skin). Adhesion is assessed daily when patches are insitu. The mean adhesion score will be derived from its individual adhesion scores at each assessment time point, averaged across all the equally spaced time points (except baseline timepoint). Difference in mean adhesion score between test and reference transdermal patches will be compared using a mixed-model analysis of variance.
2 secondary outcomes
Number of subjects with treatment related adverse events will be as assessed as mild, moderate or severe and will be summarized descriptively and presented as frequency and percentage.
Time frame: 6 Months
Adhesion performance score (FDA Scale)
Time frame: 6 Months
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 14 Jun 2024.
- BackgroundBioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations (DHHS 2014). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). March 2014
- BackgroundGuidance for Industry: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs (DHHS 2018). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2018
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sancuso - Part 1 and Sancuso - Part 2 in people with Healthy Volunteers, run by Kyowa Kirin, Inc. 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 7 inclusion and 27 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 14 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. 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?
Area under the plasma concentration versus time curve AUC (0-t) (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027646, which also lists 2 linked publications.
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 14 Jun 2024.