Clinical trial NCT03673527: Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin
Official title: Open-label, Non-randomised, Single-centre, Multiple-dose, Phase 1, Pharmacokinetic Trial With a Topical Formulation of Tacrolimus in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: open-label
multiple-dose
non-randomised
non-comparative
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: Maximum Observed Drug Concentration (Cmax) of tacrolimus
timeFrame: On Days 1 and 14
Secondary outcomes:
measure: Number of adverse events (AEs) up to Day 21
timeFrame: Day -22 to Day 21
measure: Number of subjects with AEs up to Day 21
timeFrame: Day -22 to Day 21
measure: Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation
timeFrame: Day 1 to Day 21
measure: Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation
timeFrame: Day 1 to Day 21
measure: Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation
timeFrame: Day 1 to Day 21
measure: Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation
timeFrame: Day 1 to Day 21
measure: Changes in pulse from baseline to Day 21 summarised by mean and standard deviation
timeFrame: Day 1 to Day 21
measure: Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation
timeFrame: Day 1 to Day 21
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14
timeFrame: Day 1 to Day 14
measure: Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Investigational site
state: Bavaria
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: