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Tyrosine Kinase Inhibitor

Povorcitinib for Healthy Volunteers

Phase 1

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 19 to 55 years inclusive at the time of signing the ICF

Ability to swallow and retain oral medication

Must not have

History of uncontrolled respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening

Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 30

Awards & highlights

Summary

"This trial aims to study how the body processes and absorbs povorcitinib after multiple oral doses in healthy individuals."

Who is the study for?

This trial is for healthy individuals who can safely take multiple doses of a medication called Povorcitinib. The study will involve taking the drug orally to see how it's processed by their bodies.

What is being tested?

The trial is testing Povorcitinib, an oral medication, to understand how much of the drug reaches the skin and its overall behavior in the bloodstream after being taken repeatedly.

What are the potential side effects?

Since this summary does not provide specific side effects of Povorcitinib, participants should be aware that new drugs can have unexpected reactions which will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 55 years old.

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I can swallow and keep down pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had uncontrolled health issues in the last 6 months.

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I am currently on treatment for a long-term or active infection.

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I have an active tuberculosis infection or a history of tuberculosis.

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I have not had major surgery in the last 4 weeks.

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I am currently on medication that affects how drugs are processed in my body.

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I haven't taken prescription drugs in the last 14 days or nonprescription medications in the last 7 days.

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I am not pregnant or breastfeeding.

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I am not taking any medications that are not allowed in the study.

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I have been diagnosed with an autoimmune disease.

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I have or had a condition that affects how my body absorbs nutrients.

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I do not have unstable heart conditions, stroke history, blood circulation issues, or uncontrolled high blood pressure.

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My kidney function is reduced, with an eGFR below 80 mL/min/1.73 m2.

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I cannot have or handle many skin biopsies.

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I have tattoos or scars where skin samples can be taken.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK in plasma povorcitinib

Pharmacokinetic (PK) in dermal povorcitinib

Secondary study objectives

Additional povorcitinib PK parameters in plasma

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PovorcitinibExperimental Treatment1 Intervention

Povorcitinib will be administered at the protocol defined dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Povorcitinib

2024

Completed Phase 1

~30

0 / 16Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Incyte CorporationLead Sponsor

382 Previous Clinical Trials

57,034 Total Patients Enrolled

Incyte Medical MonitorStudy DirectorIncyte Corporation

31 Previous Clinical Trials

5,824 Total Patients Enrolled

~0 spots leftby Oct 2024

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