Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin (NCT03673527) | Clinical Trial Compass
CompletedPhase 1
Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin
Germany24 participantsStarted 2018-11-22
Plain-language summary
This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Healthy male and female subjects between 18 and 60 years of age, with a body mass index (BMI) between 18.5 and 30 kg/m2 inclusive
* Female subjects of childbearing potential must be confirmed not pregnant at the screening visit and use highly effective contraception during the trial.
Key Exclusion Criteria:
* Treatment with the following medications: Topical immunosuppressive drugs (e.g. tacrolimus, corticosteroids), systemic immunosuppressive/immunomodulating drugs
* Extensive UV radiation or sunlight on the application sites
* Skin diseases
* Wounded or damaged skin at the application site
* Immunosuppressed or immunocompromised individuals
* Renal or hepatic impairment or insufficiency
* Known allergy or known or suspected hypersensitivity to any component(s) of the topical formulation of tacrolimus
* Female subjects who are pregnant or lactating
What they're measuring
1
Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14
Timeframe: Up to Day 14
2
Maximum Observed Drug Concentration (Cmax) of tacrolimus