Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: topical formulation of tacrolimus

• Registration Number: NCT03673527
• Lead Sponsor: LEO Pharma

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.

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2018-11-22
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
topical formulation of tacrolimus	topical formulation of tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Drug Concentration (Cmax) of tacrolimus	On Days 1 and 14
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational site; 🇩🇪 Neu-Ulm, Bavaria, Germany