Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

Study Overview
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Brief Summary
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This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.

Detailed Description
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The purpose of this trial is to assess the safety of a topical formulation of tacrolimus. Tacrolimus is commonly used in T-cell medicated diseases. It is expected that 24 subjects will be enrolled in the trial and will be assigned to receive topical application of tacrolimus twice daily for 14 days.

Official Title
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Open-label, Non-randomised, Single-centre, Multiple-dose, Phase 1, Pharmacokinetic Trial With a Topical Formulation of Tacrolimus in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: topical formulation of tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical formulation of tacrolimus<br> | Drug: topical formulation of tacrolimus<br>* Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14 |  | Up to Day 14 | 
| Maximum Observed Drug Concentration (Cmax) of tacrolimus |  | On Days 1 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) up to Day 21 |  | Day -22 to Day 21 | 
| Number of subjects with AEs up to Day 21 |  | Day -22 to Day 21 | 
| Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation | Measurement unit: mmHg | Day 1 to Day 21 | 
| Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation | Measurement unit: bpm | Day 1 to Day 21 | 
| Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation | Measurement unit: °C | Day 1 to Day 21 | 
| Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation | Measurement unit: mmHg | Day 1 to Day 21 | 
| Changes in pulse from baseline to Day 21 summarised by mean and standard deviation | Measurement unit: bpm | Day 1 to Day 21 | 
| Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation | Measurement unit: °C | Day 1 to Day 21 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14 |  | Day 1 to Day 14 | 
| Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14 |  | Day 1 to Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open-label, multiple-dose, non-randomised, non-comparative