Healthy
Conditions
Keywords
open-label, multiple-dose, non-randomised, non-comparative
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.
Interventions
DRUGtopical formulation of tacrolimus
Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 to Day 21 | Measurement unit: mmHg |
| Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation | Day 1 to Day 21 | Measurement unit: bpm |
| Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation | Day 1 to Day 21 | Measurement unit: °C |
| Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation | Day 1 to Day 21 | Measurement unit: mmHg |
| Changes in pulse from baseline to Day 21 summarised by mean and standard deviation | Day 1 to Day 21 | Measurement unit: bpm |
| Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation | Day 1 to Day 21 | Measurement unit: °C |
| 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 | — |
Countries
Germany
Contacts
STUDY_DIRECTORMedical Expert
LEO Pharma
Outcome results
None listed