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Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

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ClinicalTrials.gov Identifier: NCT03673527
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Healthy Drug: topical formulation of tacrolimus Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open-label, Non-randomised, Single-centre, Multiple-dose, Phase 1, Pharmacokinetic Trial With a Topical Formulation of Tacrolimus in Healthy Subjects
Actual Study Start Date : November 22, 2018
Actual Primary Completion Date : February 4, 2019
Actual Study Completion Date : February 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Experimental: topical formulation of tacrolimus Drug: topical formulation of tacrolimus
Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Twelve Hours (AUC0-12) of tacrolimus on Days 1 and 14 [ Time Frame: Up to Day 14 ]
  2. Maximum Observed Drug Concentration (Cmax) of tacrolimus [ Time Frame: On Days 1 and 14 ]

Secondary Outcome Measures :
  1. Number of adverse events (AEs) up to Day 21 [ Time Frame: Day -22 to Day 21 ]
  2. Number of subjects with AEs up to Day 21 [ Time Frame: Day -22 to Day 21 ]
  3. Absolute values of systolic and diastolic blood pressure at Days 1, 2, 14, and 21 summarised by mean and standard deviation [ Time Frame: Day 1 to Day 21 ]
    Measurement unit: mmHg

  4. Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation [ Time Frame: Day 1 to Day 21 ]
    Measurement unit: bpm

  5. Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation [ Time Frame: Day 1 to Day 21 ]
    Measurement unit: °C

  6. Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation [ Time Frame: Day 1 to Day 21 ]
    Measurement unit: mmHg

  7. Changes in pulse from baseline to Day 21 summarised by mean and standard deviation [ Time Frame: Day 1 to Day 21 ]
    Measurement unit: bpm

  8. Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation [ Time Frame: Day 1 to Day 21 ]
    Measurement unit: °C

  9. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of tacrolimus on Day 14 [ Time Frame: Day 1 to Day 14 ]
  10. Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14 [ Time Frame: Day 1 to Day 14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673527


Locations
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Germany
Investigational site
Neu-Ulm, Bavaria, Germany, 89231
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03673527    
Other Study ID Numbers: LP0121-1388
2018-001959-12 ( EudraCT Number )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LEO Pharma:
open-label
multiple-dose
non-randomised
non-comparative
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action