None listed
Conditions
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.
Interventions
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.
Sponsors
INC Research Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed