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

NCT07588139 | Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB054707-113
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

INCB054707

Outcome Measures

Primary Outcomes (12)

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

  Defined as the maximum observed plasma concentration.

  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.

  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.

  Up to Day 12

• Pharmacokinetics Parameter: Cmax of dISF povorcitinib

  Defined as the maximum observed plasma concentration.

  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.

  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.

  Up to Day 12

• Pharmacokinetics Parameter: Cmax of plasma ruxolitinib

  Defined as the maximum observed plasma concentration.

  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.

  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.

  Up to Day 12

• Pharmacokinetics Parameter: Cmax of plasma povorcitinib

  Defined as the maximum observed plasma concentration.

  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.

  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.

  Up to Day 12

Secondary Outcomes (21)

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 28

• Pharmacokinetics Parameter: tmax of dISF ruxolitinib

  Up to Day 12

• Pharmacokinetics Parameter: t½ of dISF ruxolitinib

  Up to Day 12

• Pharmacokinetics Parameter: CL/F of dISF ruxolitinib

  Up to Day 12

• Pharmacokinetics Parameter: Vz/F of dISF ruxolitinib

  Up to Day 12

Study Arms (3)

Cohort 1: Ruxolitinib 1.5 % Cream

EXPERIMENTAL

Ruxolitinib cream applied topically twice daily.

Drug: Ruxolitinib

Cohort 2: Povorcitinib

EXPERIMENTAL

Povorcitinib will be administered at the protocol defined dose.

Drug: Povorcitinib

Cohort 3: Povorcitinib

EXPERIMENTAL

Povorcitinib will be administered at the protocol defined dose.

Drug: Povorcitinib

Interventions

Povorcitinib DRUG

Oral; Tablet

Also known as: INCB054707

Cohort 2: Povorcitinib; Cohort 3: Povorcitinib

Ruxolitinib DRUG

Ruxolitinib cream applied topically.

Cohort 1: Ruxolitinib 1.5 % Cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Ability to swallow and retain oral medication.
• Willingness to avoid pregnancy or fathering children.

You may not qualify if:

• 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.
• Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
• Any malignancies or history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
• Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
• Any major surgery within 4 weeks of screening.
• Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma-only donation).
• Blood transfusion within 4 months of check-in (Day -1).
• Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).
• Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
• Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
• Has received a live vaccine (including attenuated) or anticipation of need for such a vaccine during the study within 3 months prior to the first dose of study drug. Note: Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, chickenpox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.
• Medical or self-reported history of alcoholism within 3 months of screening.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Axis Clinicals

Dilworth, Minnesota, 56529, United States

RECRUITING

MeSH Terms

Interventions

ruxolitinib

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 19, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)