Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

NCT03673527 | Completed Phase 1

• 2 other identifiers: LP0121-13882018-001959-12
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

open-label; multiple-dose; non-randomised; non-comparative

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

• Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation

  Day 1 to Day 21

• Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation

  Day 1 to Day 21

Study Arms (1)

topical formulation of tacrolimus

EXPERIMENTAL

Drug: topical formulation of tacrolimus

Interventions

topical formulation of tacrolimus DRUG

Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).

topical formulation of tacrolimus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Investigational site

Neu-Ulm, Bavaria, 89231, Germany

Location

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: September 17, 2018
• Study Start: November 22, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 11, 2019
• Last Updated: April 28, 2026

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)