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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

1. Juni 2026 aktualisiert von: Incyte Corporation

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Interventionell

Einschreibung (Geschätzt)

24

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Incyte Corporation Call Center (US)
  • Telefonnummer: 1.855.463.3463
  • E-Mail: medinfo@incyte.com

Studieren Sie die Kontaktsicherung

  • Name: Incyte Corporation Call Center (ex-US)
  • Telefonnummer: +800 00027423
  • E-Mail: eumedinfo@incyte.com

Studienorte

    • Minnesota
      • Dilworth, Minnesota, Vereinigte Staaten, 56529
        • Rekrutierung
        • Axis Clinicals

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cohort 1: Ruxolitinib 1.5 % Cream
Ruxolitinib cream applied topically twice daily.
Ruxolitinib cream applied topically.
Experimental: Cohort 2: Povorcitinib
Povorcitinib will be administered at the protocol defined dose.
Oral; Tablette
Andere Namen:
  • INCB054707
Experimental: Cohort 3: Povorcitinib
Povorcitinib will be administered at the protocol defined dose.
Oral; Tablette
Andere Namen:
  • INCB054707

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib
Zeitfenster: Up to Day 12
Defined as the maximum observed plasma concentration.
Up to Day 12
Pharmacokinetics Parameter: AUClast of dISF ruxolitinib
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
Defined as the maximum observed plasma concentration.
Up to Day 12
Pharmacokinetics Parameter: AUClast of dISF povorcitinib
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
Defined as the maximum observed plasma concentration.
Up to Day 12
Pharmacokinetics Parameter: AUClast of plasma ruxolitinib
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
Defined as the maximum observed plasma concentration.
Up to Day 12
Pharmacokinetics Parameter: AUClast of plasma povorcitinib
Zeitfenster: Up to Day 12
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
Zeitfenster: Up to Day 12
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
Up to Day 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Zeitfenster: Up to Day 28
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.
Up to Day 28
Pharmacokinetics Parameter: tmax of dISF ruxolitinib
Zeitfenster: Up to Day 12
Defined as the time to maximum concentration.
Up to Day 12
Pharmacokinetics Parameter: t½ of dISF ruxolitinib
Zeitfenster: Up to Day 12
Defined as the apparent terminal-phase disposition half-life.
Up to Day 12
Pharmacokinetics Parameter: CL/F of dISF ruxolitinib
Zeitfenster: Up to Day 12
Defined as the apparent clearance.
Up to Day 12
Pharmacokinetics Parameter: Vz/F of dISF ruxolitinib
Zeitfenster: Up to Day 12
Defined as the apparent volume of distribution.
Up to Day 12
Pharmacokinetics Parameter: λz of dISF ruxolitinib
Zeitfenster: Up to Day 12
Defined as the terminal-phase disposition rate constant.
Up to Day 12
Pharmacokinetics Parameter: tmax of dISF povorcitinib
Zeitfenster: Up to Day 12
Defined as the time to maximum concentration.
Up to Day 12
Pharmacokinetics Parameter: t½ of dISF povorcitinib
Zeitfenster: Up to Day 12
Defined as the apparent terminal-phase disposition half-life.
Up to Day 12
Pharmacokinetics Parameter: CL/F of dISF povorcitinib
Zeitfenster: Up to Day 12
Defined as the apparent clearance.
Up to Day 12
Pharmacokinetics Parameter: Vz/F of dISF povorcitinib
Zeitfenster: Up to Day 12
Defined as the apparent volume of distribution.
Up to Day 12
Pharmacokinetics Parameter: λz of dISF povorcitinib
Zeitfenster: Up to Day 12
Defined as the terminal-phase disposition rate constant.
Up to Day 12
Pharmacokinetics Parameter: tmax of plasma ruxolitinib
Zeitfenster: Up to Day 12
Defined as the time to maximum concentration.
Up to Day 12
Pharmacokinetics Parameter: t½ of plasma ruxolitinib
Zeitfenster: Up to Day 12
Defined as the apparent terminal-phase disposition half-life.
Up to Day 12
Pharmacokinetics Parameter: CL/F of plasma ruxolitinib
Zeitfenster: Up to Day 12
Defined as the apparent clearance.
Up to Day 12
Pharmacokinetics Parameter: Vz/F of plasma ruxolitinib
Zeitfenster: Up to Day 12
Defined as the apparent volume of distribution.
Up to Day 12
Pharmacokinetics Parameter: λz of plasma ruxolitinib
Zeitfenster: Up to Day 12
Defined as the terminal-phase disposition rate constant.
Up to Day 12
Pharmacokinetics Parameter: tmax of plasma povorcitinib
Zeitfenster: Up to Day 12
Defined as the time to maximum concentration.
Up to Day 12
Pharmacokinetics Parameter: t½ of plasma povorcitinib
Zeitfenster: Up to Day 12
Defined as the apparent terminal-phase disposition half-life.
Up to Day 12
Pharmacokinetics Parameter: CL/F of plasma povorcitinib
Zeitfenster: Up to Day 12
Defined as the apparent clearance.
Up to Day 12
Pharmacokinetics Parameter: Vz/F of plasma povorcitinib
Zeitfenster: Up to Day 12
Defined as the apparent volume of distribution.
Up to Day 12
Pharmacokinetics Parameter: λz of plasma povorcitinib
Zeitfenster: Up to Day 12
Defined as the terminal-phase disposition rate constant.
Up to Day 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Incyte Medical Monitor, Incyte Corporation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Mai 2026

Primärer Abschluss (Geschätzt)

3. September 2026

Studienabschluss (Geschätzt)

19. September 2026

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • INCB054707-113

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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