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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.
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
Secondary ID [1] 296817 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 310705 0
Condition category
Condition code
Neurological 309406 309406 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313104 0
Treatment: Drugs
Comparator / control treatment
Transdermal patch matching description of active patch without API (fingolimod)
Control group
Placebo

Outcomes
Primary outcome [1] 308355 0
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.
Timepoint [1] 308355 0
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.
Primary outcome [2] 308433 0
Assess skin adhesion of two formulations of fingolimod patch. Skin adhesion will be assessed through the Adhesion parameters [12-point categorical scale (0-11)].
Timepoint [2] 308433 0
Adhesion Parameters: assessed every 24 hours +/-1 hours from the time of patch application until removal.
Secondary outcome [1] 354709 0
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.
Timepoint [1] 354709 0
Adverse Events will be recorded from time of participant's check in (day-1) until Day 29 post dose.

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.
Minimum age
25 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12669 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 25091 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 301390 0
Commercial sector/Industry
Name [1] 301390 0
Corium International, Inc.
Address [1] 301390 0
235 Constitution Drive Menlo Park, California 94025 USA
Country [1] 301390 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
INC Research Australia Pty Ltd
Address
159 Port Road
Hindmarsh, SA 5007
Adelaide, Australia
Country
Australia
Secondary sponsor category [1] 301058 0
None
Name [1] 301058 0
Address [1] 301058 0
Country [1] 301058 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302127 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 302127 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 302127 0
Australia
Date submitted for ethics approval [1] 302127 0
21/11/2018
Approval date [1] 302127 0
Ethics approval number [1] 302127 0

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.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 89210 0
Dr James Kuo
Address 89210 0
Scientia Clinical Research Ltd, Bright Building Level 5, Corner High and Avoca Streets, Randwick, NSW 2031
Country 89210 0
Australia
Phone 89210 0
+61 293825800
Fax 89210 0
Email 89210 0
james.kuo@scientiaclinicalresearch.com.au
Contact person for public queries
Name 89211 0
Ms Lisa Nelson
Address 89211 0
Scientia Clinical Research Ltd, Bright Building Level 5, Corner High and Avoca Streets, Randwick, NSW 2031
Country 89211 0
Australia
Phone 89211 0
+61 438 008 816
Fax 89211 0
Email 89211 0
lisa.nelson@scientiaclinicalresearch.com.au
Contact person for scientific queries
Name 89212 0
Ms Vaeling Miller
Address 89212 0
Corium International, Inc
235 Constitution Drive
Menlo Park
CA
94024, USA
Country 89212 0
United States of America
Phone 89212 0
+1 408 203 1726
Fax 89212 0
Email 89212 0
vmiller@coriumintl.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a Phase 1 study, only aggregate data may be posted/published.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Other
'Other' documents specified
Selected summary information may be available from the CSR.
Summary results
Not applicable