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Trial registered on ANZCTR
Registration number
ACTRN12618002016213p
Ethics application status
Submitted, not yet approved
Date submitted
6/12/2018
Date registered
17/12/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A study to evaluate the safety and tolerability of an investigational transdermal patch containing Fingolimod in healthy volunteers.
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Scientific title
An Exploratory Clinical Study to Evaluate the Safety and Skin Tolerability of Multiple Formulations of Once-Weekly Investigational Transdermal Delivery System containing Fingolimod in Healthy Volunteers
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Secondary ID [1]
296817
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis
310705
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Condition category
Condition code
Neurological
309406
309406
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0
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Multiple sclerosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single Cohort: Four Treatment randomizations each including a combination of Transdermal Patch one each Fin1 (71 microgram fingolimod lactate/day), Fin7 (108 microgram fingolimod HCL/day) and Placebo (Fin3) applied concurrently to either arm as randomized (left or right) for a continuous period of 7 days
Clinical staff will review patch daily as per protocol and anything sticking to the patch or overlay, will be required to report potential patch adhesion to clothing.
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Intervention code [1]
313104
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Treatment: Drugs
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Comparator / control treatment
Transdermal patch matching description of active patch without API (fingolimod)
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Control group
Placebo
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Outcomes
Primary outcome [1]
308355
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Assess skin tolerability of two formulations of Fingolimod patch. Skin tolerability will be assessed through the use of two scales; Dermal Response Scale (8-point categorical scale (0-7) and Other Effects Scale (6-point categorical scale (0-5). Both scales will be used to assess the single primary outcome of skin tolerability.
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Assessment method [1]
308355
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Timepoint [1]
308355
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Skin irritation for each transdermal patch will be assessed and scored post-patch removal for at least 72-hours. Adhesion Parameters: assessed every 24 hours +/-1 hours from the time of patch application until removal.
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Primary outcome [2]
308433
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Assess skin adhesion of two formulations of fingolimod patch. Skin adhesion will be assessed through the Adhesion parameters [12-point categorical scale (0-11)].
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Assessment method [2]
308433
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Timepoint [2]
308433
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Adhesion Parameters: assessed every 24 hours +/-1 hours from the time of patch application until removal.
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Secondary outcome [1]
354709
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Determine safety by assessing AE’s, use of concomitant medications, physical examination (respiratory, cardiovascular, and gastrointestinal systems, weight, and BMI), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), clinical lab sampling (hematology and chemistry) and urine (urinalysis) and 12-lead ECGs.
This is a composite outcome, safety is assessed by each of the components.
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Assessment method [1]
354709
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Timepoint [1]
354709
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Adverse Events will be recorded from time of participant's check in (day-1) until Day 29 post dose.
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Eligibility
Key inclusion criteria
General
1. Healthy, adult, Caucasian females and males aged 25 to 50 years (inclusive) on the day of randomization. Enrollment will aim for 100 percent females; however, up to 25 percent males may be enrolled per the Sponsor’s approval
2. Has a body mass index between 18-32 kg/m^2 (inclusive).
3. Have a Fitzpatrick skin type of I, II, or III
4. Must be willing and able to understand and comply with the scheduled study visits, treatment plans, laboratory tests, and other procedures by providing a signed and dated written informed consent prior to the initiation of any study procedures.
5. Women of child-bearing potential and men should be sexually inactive (abstinent). Abstinence, defined as complete avoidance of heterosexual intercourse, is an acceptable form of contraception.
6. Willing and able to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) NSAID analgesic therapy, 30 days prior to Day 1 and until completion of the Study Exit Visit.
7. If the subject is receiving allowed medications for the treatment of non-excluded medical conditions, the dose must be stable for at least 28 days before randomization on Day 1.
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Minimum age
25
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
General
1. Participation in another clinical study with an IP or device within 30 days or 5 half-lives, whichever is longer, prior to screening.
2. Plasma donation within 28 days of screening or any blood donation or blood loss greater than 500 mL within 3 months of screening.
3. Has skin color that may not allow reliable evaluation of irritation.
4. Female subjects with a positive pregnancy test or lactating.
5. Has intolerance to venipuncture and/or inability to comply with the blood sampling required for this study.
6. Has cuts, scratches/abrasions, scars, breaks in the skin surface, recent tattoos (within the last 6 months) at the application site, skin with excessive hair, indications of sunburn, excessive skin tanning, stretch marks and/or similar abnormalities at the intended application sites
7. Unwilling to refrain from using tanning salons, saunas, or from sunbathing during the course of the study. Unwilling to avoid shaving of the application site, waxing of the application site, or using lotion hair remover on or near application site from 48 hours before patch application and during the conduct of the study.
8. Has a history of or is currently consuming high caffeine levels
9. Smokes more than 20 cigarettes per day
10. Presence of any major psychiatric disorder
11. Significant cardiovascular disease
12. Significant or chronic lung disease
13. Diabetes complicated
14. Known or suspected systemic infection
15. History of severe allergy/hypersensitivity reactions
16. History of cancer
17. Transient ischemic attack or stroke in the last 3 years.
18. Myocardial infarction, hospitalization for unstable angina or arrhythmia or unexplained syncope
19. Clinically important infection
20. Any medical or surgical procedure or trauma within 28 days
21. Current serious or unstable clinically important illness
22. Has a history of allergic reactions to medical grade adhesive tapes, sunscreens, cosmetics, lotions, fragrances, or latex.
23. Use of adjuvant analgesics
24. Use of muscle relaxants
25. Use of any topical medication in the areas intended for patch application
26. Use of any topical products without medicinal ingredient (including but not limited to perfumes, body lotions, sunscreens, spray or patch oils, creams and alcohol) on the area intended for patch application within 48 hours prior to the first patch application
27. Prior or current use of fingolimod hydrochloride, or piperidine derivatives and related drugs.
28. Clinically important abnormality
29. Heart rate less than or equal to 60 bpm.
30. Clinically significant hypertension
31. Any clinically significant abnormality in electrocardiogram (ECG) rhythm
32. A positive pregnancy test at screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assigned a randomization number and allocated to a treatment group based on a randomization schedule
Allocation involved contacting the holder ( off-site pharmacist) of the allocation schedule who will then assign the treatment
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety
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Statistical methods / analysis
Analyses will be of a descriptive nature. Descriptive statistics will consist of summary statistics (number of non-missing observations, mean, standard deviation, minimum, median, and maximum) for continuous data and frequency counts and percentages for categorical data.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/01/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
12669
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Scientia Clinical Research - Randwick
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Recruitment postcode(s) [1]
25091
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
301390
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Commercial sector/Industry
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Name [1]
301390
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Corium International, Inc.
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Address [1]
301390
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235 Constitution Drive Menlo Park, California 94025 USA
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Country [1]
301390
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
INC Research Australia Pty Ltd
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Address
159 Port Road
Hindmarsh, SA 5007
Adelaide, Australia
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Country
Australia
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Secondary sponsor category [1]
301058
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None
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Name [1]
301058
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Address [1]
301058
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Country [1]
301058
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
302127
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
302127
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55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
302127
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Australia
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Date submitted for ethics approval [1]
302127
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21/11/2018
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Approval date [1]
302127
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Ethics approval number [1]
302127
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Summary
Brief summary
This research project is being conducted to investigate the safety and tolerability of a single application of a transdermal drug delivery system containing fingolimod HCl when administered to healthy volunteers.
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Trial website
None
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Trial related presentations / publications
None
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Public notes
None
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Contacts
Principal investigator
Name
89210
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Dr James Kuo
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Address
89210
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Scientia Clinical Research Ltd, Bright Building Level 5, Corner High and Avoca Streets, Randwick, NSW 2031
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Country
89210
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Australia
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Phone
89210
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+61 293825800
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Fax
89210
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Email
89210
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[email protected]
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Contact person for public queries
Name
89211
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Ms Lisa Nelson
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Address
89211
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Scientia Clinical Research Ltd, Bright Building Level 5, Corner High and Avoca Streets, Randwick, NSW 2031
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Country
89211
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Australia
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Phone
89211
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+61 438 008 816
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Fax
89211
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Email
89211
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[email protected]
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Contact person for scientific queries
Name
89212
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Ms Vaeling Miller
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Address
89212
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Corium International, Inc
235 Constitution Drive
Menlo Park
CA
94024, USA
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Country
89212
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United States of America
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Phone
89212
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+1 408 203 1726
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Fax
89212
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Email
89212
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
As this is a Phase 1 study, only aggregate data may be posted/published.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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