Healthy ParticipantsPhase 1NCT06505265
A Study to Evaluate Skin and Plasma Pharmacokinetic of Multiple Doses of Povorcitinib After Oral Administration in Healthy Participants
A Phase 1 study testing Povorcitinib in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Povorcitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 18 Sep 2024
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (ie, a QTcF interval > 440 milliseconds for males and > 460 milliseconds for females, QRS interval > 120 milliseconds, or PR interval > 220 milliseconds). Note: In the event a value is exclusionary, a single ECG will be repeated twice, and the average of the 3 readings will be used to determine if a participant should be excluded.
- 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.
Show all 36Show fewer
- 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.
- Hemoglobin, WBC count, platelet count, or absolute neutrophil count less than the laboratory LLN at screening or check-in, confirmed by repeat testing. Hemoglobin, WBC, platelet, and neutrophil abnormalities must also be clinically significant in the opinion of the investigator to be exclusionary.
- 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.
- 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.
- Receipt of a live or nonlive (including attenuated) vaccine within 3 months before the first dose of study drug or anticipation of a need for such a vaccine during the study.
- History of significant alcohol use within 3 months before 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 = a 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 drug, 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 of study drug, with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database [2024] 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.
- Current use of prohibited medication as described in the protocol.
- 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 or any JAK inhibitor (refer to the IB).
- Inability to undergo venipuncture or tolerate venous access.
- Inability to undergo or tolerate multiple skin biopsies.
- History of tobacco- or nicotine-containing product use within 1 month before screening.
- Use of prescription drugs (including hormonal contraceptives) within 14 days before study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days before study drug administration. However, occasional, standard-dose paracetamol and ibuprofen and standard-dose vitamins are permitted. Mega-dose vitamins or supplements are not permissible.
- Excessive exercise (eg, Ironman®, triathlon) within 7 days before check-in (Day -1).
- Women who are pregnant or breastfeeding.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- Tattoo or scarring at skin sample sites.
- History of keloid or hypertrophic scarring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Skin and Plasma Pharmacokinetic Study of Multiple Doses of Povorcitinib After Oral Administration in Healthy Participants
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
- Being tested
- Povorcitinib
- 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
| Study group | Role | What they receive |
|---|---|---|
| Povorcitinib | Experimental | Povorcitinib 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.
Pharmacokinetic (PK) in dermal povorcitinib
Povorcitinib concentration in dermal.
Measured: Up to Day 17
PK in plasma povorcitinib
Povorcitinib concentration in plasma.
Measured: Up to Day 17
Secondary outcomes (2)
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 30
Additional povorcitinib PK parameters in plasma
Additional povorcitinib concentration in plasma.
Measured: Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start12 Aug 2024
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505265
- Sponsor's protocol ID
- INCB054707-112
- Status last verified
- Sep 2024
- First submitted
- 8 Jul 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2025 Dec;17(24):1747-1758. doi: 10.1080/17576180.2025.2612493. Epub 2026 Jan 8.
PubMed 41504465
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Skin and Plasma Pharmacokinetic Study of Multiple Doses of Povorcitinib After Oral Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT06505265
- Acronym / sponsor ID
- INCB054707-112
- Conditions
- Healthy Participants
- Keywords
- INCB054707
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Povorcitinib | Experimental | Drug: PovorcitinibPovorcitinib will be administered at the protocol defined dose. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (36 listed)
- 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).
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (ie, a QTcF interval > 440 milliseconds for males and > 460 milliseconds for females, QRS interval > 120 milliseconds, or PR interval > 220 milliseconds). Note: In the event a value is exclusionary, a single ECG will be repeated twice, and the average of the 3 readings will be used to determine if a participant should be excluded.
- Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect the absorption of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PovorcitinibAlso: INCB054707Oral; Tablet | Drug | Povorcitinib |
Primary outcome
Pharmacokinetic (PK) in dermal povorcitinib
Time frame: Up to Day 17
Povorcitinib concentration in dermal.
PK in plasma povorcitinib
Time frame: Up to Day 17
Povorcitinib concentration in plasma.
2 secondary outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 30
Additional povorcitinib PK parameters in plasma
Time frame: Up to Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 41504465Xun 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. 2025 Dec;17(24):1747-1758. doi: 10.1080/17576180.2025.2612493. Epub 2026 Jan 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Povorcitinib 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 36 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 26 Sep 2024. 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?
Pharmacokinetic (PK) in dermal povorcitinib (time frame: Up to Day 17). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505265, which also lists 1 linked publication.
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 26 Sep 2024.