A Study to Evaluate Skin and Plasma Pharmacokinetic of Multiple Doses of Povorcitinib After Oral Administration in Healthy Participants

NCT06505265 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB054707-112
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the effect of multiple doses of orally administered povorcitinib on skin PK and to characterize plasma PK parameters of povorcitinib following multiple doses of orally administered povorcitinib.in healthy participants.

Conditions

Healthy Participants

Keywords

INCB054707

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic (PK) in dermal povorcitinib

  Povorcitinib concentration in dermal.

  Up to Day 17

• PK in plasma povorcitinib

  Povorcitinib concentration in plasma.

  Up to Day 17

Secondary Outcomes (2)

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

  Up to Day 30

• Additional povorcitinib PK parameters in plasma

  Up to Day 17

Study Arms (1)

Povorcitinib

EXPERIMENTAL

Povorcitinib will be administered at the protocol defined dose.

Drug: Povorcitinib

Interventions

Povorcitinib DRUG

Oral; Tablet

Also known as: INCB054707

Povorcitinib

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to comprehend and willingness to sign a written ICF for the study.
• Age 19 to 55 years inclusive at the time of signing the ICF.
• Body mass index between 18.0 and 30.5 kg/m2, inclusive. Up to 25% of participants with a BMI up to 32.0 kg/m2 may be enrolled.
• 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 based on the protocol defined criteria.

You may not qualify if:

• History of uncontrolled respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
• History of an autoimmune disease diagnosis (eg, myasthenia gravis).
• History of unstable cardiovascular disease; cerebrovascular, peripheral vascular, or thrombotic disease; or uncontrolled hypertension (ie, systolic blood pressure \> 140 mmHg or diastolic blood pressure \>90 mmHg at screening, confirmed by repeat testing).
• Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect the absorption of study drug.
• History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
• Current or recent (within 3 months before screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
• Resting pulse rate \< 40 bpm or \> 100 bpm at screening, confirmed by repeat testing.
• Vitamin B12 and folate levels at screening that are clinically significant in the opinion of the investigator. Note: Assessment of vitamin B12 and folate levels may be repeated once if outside the reference range.
• ALT, AST, ALP, or total bilirubin \> 1.25 × the laboratory-defined ULN at screening or check-in, confirmed by repeat testing (except participants with Gilbert's disease, for whom total bilirubin must be ≤ 2.0 × ULN).
• An eGFR \< 80 mL/min/1.73 m2, based on the site's standard formula, at screening. Note: Assessment of eGFR may be repeated once if outside the reference range.
• Any major surgery within 4 weeks before screening.
• Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks before screening (within 2 weeks for plasma-only donation).
• Blood transfusion within 4 months before 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion, Inc

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• Xun Z, Zhang L, Wen H, McGee R, Wang P. Development and validation of a bioanalytical method to quantify povorcitinib in human skin with clinical application. Bioanalysis. 2026 Jan 8:1-12. doi: 10.1080/17576180.2025.2612493. Online ahead of print.

  PMID: 41504465 DERIVED

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 17, 2024
• Study Start: August 12, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)