A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIncyte Corporation

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Povorcitinib

    Drug

    Oral; Tablet

  • Ruxolitinib

    Drug

    Ruxolitinib cream applied topically.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Cohort 1: Ruxolitinib 1.5 % CreamExperimental treatment 1 intervention
Group B: Cohort 2: PovorcitinibExperimental treatment 1 intervention
Group C: Cohort 3: PovorcitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib

Defined as the maximum observed plasma concentration.

Time frame
Up to Day 12
2

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
3

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
4

Pharmacokinetics Parameter: Cmax of dISF povorcitinib

Defined as the maximum observed plasma concentration.

Time frame
Up to Day 12

Secondary outcomes

1

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
2

Pharmacokinetics Parameter: tmax of dISF ruxolitinib

Defined as the time to maximum concentration.

Time frame
Up to Day 12
3

Pharmacokinetics Parameter: t½ of dISF ruxolitinib

Defined as the apparent terminal-phase disposition half-life.

Time frame
Up to Day 12
4

Pharmacokinetics Parameter: CL/F of dISF ruxolitinib

Defined as the apparent clearance.

Time frame
Up to Day 12

Other outcomes

Sponsors and contacts

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