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Healthy ParticipantsPhase 1NCT07588139

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

A Phase 1 study testing Povorcitinib and Ruxolitinib in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Povorcitinib and Ruxolitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
18 May 2026to 5 Oct 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females (1 unit = 8 oz of beer or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
  • Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study treatment with another investigational medication or current enrollment in another investigational drug study.
  • Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose/application of study treatment with strong inducers or strong and moderate inhibitors of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database for prohibited drugs.
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
  • Known hypersensitivity or severe reaction to povorcitinib or any excipients of povorcitinib, to ruxolitinib or any excipients of ruxolitinib or any JAK inhibitors.
  • Inability to undergo venipuncture or tolerate venous access.
  • History of tobacco or nicotine containing product use within 1 month of screening.
  • Use of prescription drugs (including hormonal contraceptives) within 14 days of study treatment administration/application or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days before study treatment administration/application. However, occasional and standard dose paracetamol, acetaminophen, ibuprofen, and standard dose vitamins are permitted. Mega dose vitamins or supplements are not permissible.
  • Women who are pregnant or breastfeeding.
  • Any condition that would interfere with full participation in the study, including administration/application of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Excessive exercise (ie Iron man®, triathlon, etc) within 7 days before check-in (Day -1).
  • Tattoo or scarring at skin sample sites.
  • Participants prone to keloid or hypertrophic scar formation or any known wound healing disorder.
  • Not willing to avoid excessive sun exposure, steam baths, sauna, swimming, and other strenuous activities for 14 days after Day 12 to ensure good tissue regeneration.
  • Pronounced hairiness on the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, that may negatively affect dose application, probe placement, and/or sample testing.
  • Not willing to refrain from shaving the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, or using skin care products on the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, for at least 5 days before Day 1.
  • Not willing to avoid sunbathing, using tanning salons, or using spray/lotion tanning agents within 7 days prior to Day 1 dose administration/application.
  • Presence of needle phobia.
  • Increased risk of thrombosis (eg, personal or first-degree relative[s] history of deep vein thrombosis).
  • Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Axis Clinicals

    Dilworth, Minnesota, 56529

Other trials in United States

About this study

Official title: An Open-Label, Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants

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.

Being tested
Povorcitinib, Ruxolitinib
Keywords
INCB054707

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PovorcitinibDrug

    Also called INCB054707

    Oral; Tablet

  • RuxolitinibDrug

    Ruxolitinib cream applied topically.

Study groups in NCT07588139
Study groupRoleWhat they receive
Cohort 1: Ruxolitinib 1.5 % CreamExperimentalRuxolitinib cream applied topically twice daily.
Receives: Drug: Ruxolitinib
Cohort 2: PovorcitinibExperimentalPovorcitinib will be administered at the protocol defined dose.
Receives: Drug: Povorcitinib
Cohort 3: PovorcitinibExperimentalPovorcitinib will be administered at the protocol defined dose.
Receives: Drug: Povorcitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Defined as the maximum observed plasma concentration.

    Measured: 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.

    Measured: 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.

    Measured: Up to Day 12

  4. Pharmacokinetics Parameter: Cmax of dISF povorcitinib

    Defined as the maximum observed plasma concentration.

    Measured: Up to Day 12

  5. Pharmacokinetics Parameter: AUClast of dISF povorcitinib

    Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.

    Measured: Up to Day 12

  6. Pharmacokinetics Parameter: AUC∞ of dISF povorcitinib

    Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.

    Measured: Up to Day 12

  7. Pharmacokinetics Parameter: Cmax of plasma ruxolitinib

    Defined as the maximum observed plasma concentration.

    Measured: Up to Day 12

  8. Pharmacokinetics Parameter: AUClast of plasma ruxolitinib

    Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.

    Measured: Up to Day 12

  9. Pharmacokinetics Parameter: AUC∞ of plasma ruxolitinib

    Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.

    Measured: Up to Day 12

  10. Pharmacokinetics Parameter: Cmax of plasma povorcitinib

    Defined as the maximum observed plasma concentration.

    Measured: Up to Day 12

  11. Pharmacokinetics Parameter: AUClast of plasma povorcitinib

    Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.

    Measured: Up to Day 12

  12. Pharmacokinetics Parameter: AUC∞ of plasma povorcitinib

    Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.

    Measured: Up to Day 12

Secondary outcomes (21)
  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.

    Measured: Up to Day 28

  2. Pharmacokinetics Parameter: tmax of dISF ruxolitinib

    Defined as the time to maximum concentration.

    Measured: Up to Day 12

  3. Pharmacokinetics Parameter: t½ of dISF ruxolitinib

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

    Measured: Up to Day 12

  4. Pharmacokinetics Parameter: CL/F of dISF ruxolitinib

    Defined as the apparent clearance.

    Measured: Up to Day 12

  5. Pharmacokinetics Parameter: Vz/F of dISF ruxolitinib

    Defined as the apparent volume of distribution.

    Measured: Up to Day 12

  6. Pharmacokinetics Parameter: λz of dISF ruxolitinib

    Defined as the terminal-phase disposition rate constant.

    Measured: Up to Day 12

  7. Pharmacokinetics Parameter: tmax of dISF povorcitinib

    Defined as the time to maximum concentration.

    Measured: Up to Day 12

  8. Pharmacokinetics Parameter: t½ of dISF povorcitinib

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

    Measured: Up to Day 12

  9. Pharmacokinetics Parameter: CL/F of dISF povorcitinib

    Defined as the apparent clearance.

    Measured: Up to Day 12

  10. Pharmacokinetics Parameter: Vz/F of dISF povorcitinib

    Defined as the apparent volume of distribution.

    Measured: Up to Day 12

  11. Pharmacokinetics Parameter: λz of dISF povorcitinib

    Defined as the terminal-phase disposition rate constant.

    Measured: Up to Day 12

  12. Pharmacokinetics Parameter: tmax of plasma ruxolitinib

    Defined as the time to maximum concentration.

    Measured: Up to Day 12

  13. Pharmacokinetics Parameter: t½ of plasma ruxolitinib

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

    Measured: Up to Day 12

  14. Pharmacokinetics Parameter: CL/F of plasma ruxolitinib

    Defined as the apparent clearance.

    Measured: Up to Day 12

  15. Pharmacokinetics Parameter: Vz/F of plasma ruxolitinib

    Defined as the apparent volume of distribution.

    Measured: Up to Day 12

  16. Pharmacokinetics Parameter: λz of plasma ruxolitinib

    Defined as the terminal-phase disposition rate constant.

    Measured: Up to Day 12

  17. Pharmacokinetics Parameter: tmax of plasma povorcitinib

    Defined as the time to maximum concentration.

    Measured: Up to Day 12

  18. Pharmacokinetics Parameter: t½ of plasma povorcitinib

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

    Measured: Up to Day 12

  19. Pharmacokinetics Parameter: CL/F of plasma povorcitinib

    Defined as the apparent clearance.

    Measured: Up to Day 12

  20. Pharmacokinetics Parameter: Vz/F of plasma povorcitinib

    Defined as the apparent volume of distribution.

    Measured: Up to Day 12

  21. Pharmacokinetics Parameter: λz of plasma povorcitinib

    Defined as the terminal-phase disposition rate constant.

    Measured: Up to Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start18 May 2026
  3. Primary completion8 Sep 2026
  4. Study completion5 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588139
Sponsor's protocol ID
INCB054707-113
Status last verified
Oct 2026
First submitted
8 May 2026
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Povorcitinib and Ruxolitinib in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib (time frame: Up to Day 12). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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