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
Recruiting now · Phase 1
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT07588139
- Run by
- Incyte Corporation
- People needed
- 24
- Starts
- 2026-05-18
- Expected to finish
- 2026-09-19
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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.
- 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.
Where it is running
- Axis Clinicals — Dilworth, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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