The purpose of this study is to evaluate the interstitial concentrations using the open-flow microperfusion device and plasma pharmacokinetics following multiple doses of povorcitinib or topical ruxolitinib cream in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Oral; Tablet
Ruxolitinib cream applied topically.
Axis Clinicals
Dilworth, Minnesota, United States
RECRUITINGPharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib
Defined as the maximum observed plasma concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUClast of dISF ruxolitinib
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUC∞ of dISF ruxolitinib
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Cmax of dISF povorcitinib
Defined as the maximum observed plasma concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUClast of dISF povorcitinib
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUC∞ of dISF povorcitinib
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Cmax of plasma ruxolitinib
Defined as the maximum observed plasma concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUClast of plasma ruxolitinib
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
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Time frame: Up to Day 12
Pharmacokinetics Parameter: AUC∞ of plasma ruxolitinib
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Cmax of plasma povorcitinib
Defined as the maximum observed plasma concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUClast of plasma povorcitinib
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: AUC∞ of plasma povorcitinib
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Time frame: Up to Day 12
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment.
Time frame: Up to Day 28
Pharmacokinetics Parameter: tmax of dISF ruxolitinib
Defined as the time to maximum concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: t½ of dISF ruxolitinib
Defined as the apparent terminal-phase disposition half-life.
Time frame: Up to Day 12
Pharmacokinetics Parameter: CL/F of dISF ruxolitinib
Defined as the apparent clearance.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Vz/F of dISF ruxolitinib
Defined as the apparent volume of distribution.
Time frame: Up to Day 12
Pharmacokinetics Parameter: λz of dISF ruxolitinib
Defined as the terminal-phase disposition rate constant.
Time frame: Up to Day 12
Pharmacokinetics Parameter: tmax of dISF povorcitinib
Defined as the time to maximum concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: t½ of dISF povorcitinib
Defined as the apparent terminal-phase disposition half-life.
Time frame: Up to Day 12
Pharmacokinetics Parameter: CL/F of dISF povorcitinib
Defined as the apparent clearance.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Vz/F of dISF povorcitinib
Defined as the apparent volume of distribution.
Time frame: Up to Day 12
Pharmacokinetics Parameter: λz of dISF povorcitinib
Defined as the terminal-phase disposition rate constant.
Time frame: Up to Day 12
Pharmacokinetics Parameter: tmax of plasma ruxolitinib
Defined as the time to maximum concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: t½ of plasma ruxolitinib
Defined as the apparent terminal-phase disposition half-life.
Time frame: Up to Day 12
Pharmacokinetics Parameter: CL/F of plasma ruxolitinib
Defined as the apparent clearance.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Vz/F of plasma ruxolitinib
Defined as the apparent volume of distribution.
Time frame: Up to Day 12
Pharmacokinetics Parameter: λz of plasma ruxolitinib
Defined as the terminal-phase disposition rate constant.
Time frame: Up to Day 12
Pharmacokinetics Parameter: tmax of plasma povorcitinib
Defined as the time to maximum concentration.
Time frame: Up to Day 12
Pharmacokinetics Parameter: t½ of plasma povorcitinib
Defined as the apparent terminal-phase disposition half-life.
Time frame: Up to Day 12
Pharmacokinetics Parameter: CL/F of plasma povorcitinib
Defined as the apparent clearance.
Time frame: Up to Day 12
Pharmacokinetics Parameter: Vz/F of plasma povorcitinib
Defined as the apparent volume of distribution.
Time frame: Up to Day 12
Pharmacokinetics Parameter: λz of plasma povorcitinib
Defined as the terminal-phase disposition rate constant.
Time frame: Up to Day 12