This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).
Investigational site
Neu-Ulm, Bavaria, Germany
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
Maximum Observed Drug Concentration (Cmax) of tacrolimus
Time frame: On Days 1 and 14
Number of adverse events (AEs) up to Day 21
Time frame: Day -22 to Day 21
Number of subjects with AEs up to Day 21
Time frame: 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
Measurement unit: mmHg
Time frame: Day 1 to Day 21
Absolute values of pulse at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Measurement unit: bpm
Time frame: Day 1 to Day 21
Absolute values of body temperature at Days 1, 2, 14, and 21 summarised by mean and standard deviation
Measurement unit: °C
Time frame: Day 1 to Day 21
Changes in systolic and diastolic blood pressure from baseline to Day 21 summarised by mean and standard deviation
Measurement unit: mmHg
Time frame: Day 1 to Day 21
Changes in pulse from baseline to Day 21 summarised by mean and standard deviation
Measurement unit: bpm
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Time frame: Day 1 to Day 21
Changes in body temperature from baseline to Day 21 summarised by mean and standard deviation
Measurement unit: °C
Time frame: Day 1 to Day 21
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
Apparent Terminal Half-life (t1/2) of tacrolimus on Day 14
Time frame: Day 1 to Day 14