About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to comprehend and willingness to sign a written ICF for the study.
Aged 18 to 65 years, inclusive, at the time of signing the ICF.
Body mass index between 18.0 and 30.5 kg/m2, inclusive.
No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
Disqualifiers
History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
Participants with any history of an autoimmune disease diagnosis.
History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
History or presence of an abnormal ECG.
Trial design
Parallel
Treatments tested in this trial
Povorcitinib
DrugOral; Tablet
Ruxolitinib
DrugRuxolitinib cream applied topically.
Treatment groups
Trial outcomes
Primary outcomes
Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib
Defined as the maximum observed plasma concentration.
Pharmacokinetics Parameter: AUClast of dISF ruxolitinib
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
Pharmacokinetics Parameter: AUC∞ of dISF ruxolitinib
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Pharmacokinetics Parameter: Cmax of dISF povorcitinib
Defined as the maximum observed plasma concentration.
Secondary outcomes
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.
Pharmacokinetics Parameter: tmax of dISF ruxolitinib
Defined as the time to maximum concentration.
Pharmacokinetics Parameter: t½ of dISF ruxolitinib
Defined as the apparent terminal-phase disposition half-life.
Pharmacokinetics Parameter: CL/F of dISF ruxolitinib
Defined as the apparent clearance.
Sponsors and contacts
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