Dermatopharmacokinetic Trial of LEO 80185 Gel

Launched by LEO PHARMA · Nov 13, 2015

Keywords

ClinConnect Summary

The study consists of two phases:

The pilot: The first part, known as the pilot study, will include 8 subjects and will evaluate pharmacokinetic profile of LEO 80185 gel and Dovobet® Ointment by measuring the amount of each of the active ingredients in the stratum corneum.

Pivotal: The second part, known as the pivotal study, is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The number of subjects in the pivotal study and the number of application sites for study medications will be bas...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form has been obtained.
• • 2. Healthy Japanese male subjects according to medical history, physical examination, ECG, vital signs and laboratory tests.
• • 3. Aged 20 to 40 years inclusive.
• • 4. Subjects with enough skin area for application of the investigational products.
• Exclusion Criteria:
• • 1. Body Mass Index outside the range 18-25 kg/m²
• • 2. History or presence of alcohol or drug abuse.
• • 3. History of allergic reaction to any medications.
• • 4. Subjects with, or with a history of, systemic or cutaneous disease that could in any way confound interpretation of the trial results (e.g. atopic dermatitis, eczema, psoriasis)
• • 5. Known or suspected hypersensitivity to any component of LEO 80185 gel or Dovobet® ointment.
• • 6. Known or suspected hepatic, renal or cardiac disorders.
• • 7. Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
• 8. Subjects with any of the following skin diseases/skin abnormalities that impede the assessment of the application site (back):
• • eczema/dermatitis or abnormal pigmentation
• • bruises or scars
• • inflammation due to sunburn
• • history and/or presence of skin allergy such as atopic dermatitis
• • history of drug hypersensitivity
• • Signs of skin irritation/disease/disorders/symptoms or blemishes at the planned site of application (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn)
• • 9. Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibiody, HIV antigen/antibody, serological test for syphilis).
• • 10. Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
• • 11. Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
• • 12. Use of any medication (systemic or topical) within 2 weeks of Day 1.
• • 13. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 months of Day 1.
• • 14. Current participation in any other interventional clinical trial.
• • 15. Previously randomised in this clinical trial.
• • 16. Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
• • 17. Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1.
• • 18. In the opinion of the (sub)investigator, participation in the trial is inappropriate.