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- Sperimentazione clinica NCT07588139
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 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
24
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Incyte Corporation Call Center (US)
- Numero di telefono: 1.855.463.3463
- Email: medinfo@incyte.com
Backup dei contatti dello studio
- Nome: Incyte Corporation Call Center (ex-US)
- Numero di telefono: +800 00027423
- Email: eumedinfo@incyte.com
Luoghi di studio
-
-
Minnesota
-
Dilworth, Minnesota, Stati Uniti, 56529
- Reclutamento
- Axis Clinicals
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Cohort 1: Ruxolitinib 1.5 % Cream
Ruxolitinib cream applied topically twice daily.
|
Ruxolitinib cream applied topically.
|
|
Sperimentale: Cohort 2: Povorcitinib
Povorcitinib will be administered at the protocol defined dose.
|
Orale; Tavoletta
Altri nomi:
|
|
Sperimentale: Cohort 3: Povorcitinib
Povorcitinib will be administered at the protocol defined dose.
|
Orale; Tavoletta
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of dISF ruxolitinib
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of dISF povorcitinib
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of plasma ruxolitinib
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of plasma povorcitinib
Lasso di tempo: 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
Lasso di tempo: Up to Day 12
|
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
|
Up to Day 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Lasso di tempo: 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
Lasso di tempo: Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of dISF ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of dISF ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of dISF ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of dISF ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: tmax of dISF povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of dISF povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of dISF povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of dISF povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of dISF povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: tmax of plasma ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of plasma ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of plasma ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of plasma ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of plasma ruxolitinib
Lasso di tempo: Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: tmax of plasma povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of plasma povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of plasma povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of plasma povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of plasma povorcitinib
Lasso di tempo: Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Incyte Medical Monitor, Incyte Corporation
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
18 maggio 2026
Completamento primario (Stimato)
3 settembre 2026
Completamento dello studio (Stimato)
19 settembre 2026
Date di iscrizione allo studio
Primo inviato
8 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
8 maggio 2026
Primo Inserito (Effettivo)
14 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- INCB054707-113
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .