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Tyrosine Kinase Inhibitor

Povorcitinib for Heart Health in Healthy Individuals

Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to swallow and retain oral medication
Age 18 to 55 years inclusive at the time of signing the ICF
Must not have
Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy and excluding appendectomy and hernia repair) that could affect the absorption of study drug or moxifloxacin
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 myasthenia gravis will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 22
Awards & highlights

Summary

"This trial aims to see how povorcitinib affects the heart's electrical activity in healthy individuals."

Who is the study for?
This trial is for healthy adults aged 18 to 55 with a body mass index between 18.0 and 30.5 kg/m2 who can swallow pills. Participants must have no significant health issues on screening tests, including clinical evaluations, lab work, and ECGs.
What is being tested?
The study is testing the effects of Povorcitinib on heart rhythm (QT/QTc interval) in healthy people compared to a placebo and Moxifloxacin, which is known to affect heart rhythm.
What are the potential side effects?
Possible side effects may include changes in heart rhythm or other cardiac-related events due to Povorcitinib's effect on the QT/QTc interval.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow and keep down pills.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major GI surgery or disease in the last 3 months.
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I haven't had serious heart, lung, kidney, stomach, hormone, blood, mental, or nerve problems in the last 6 months and don't have myasthenia gravis.
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I have a condition like Crohn's disease that affects how my body absorbs drugs.
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I have a history of heart or blood vessel diseases or my blood pressure is high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in QT interval corrected using Fridericia's formula (QTcF)
Change from Baseline in heart rate (HR)
Change from Baseline in the PR Interval (PR)
+1 more
Secondary outcome measures
Moxifloxacin concentration in plasma
Povorcitinib concentration in plasma
Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Treatment Group 2Experimental Treatment1 Intervention
Povorcitinib will be administered at the protocol defined doses.
Group II: Treatment Group 1Experimental Treatment2 Interventions
Povorcitinib and placebo will be administered at the protocol defined doses.
Group III: Treatment Group 4Active Control1 Intervention
Moxifloxacin will be administered at the protocol defined doses.
Group IV: Treatment Group 3Placebo Group1 Intervention
Placebo will be administered at the protocol defined doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Povorcitinib
2024
Completed Phase 1
~30
Placebo
1995
Completed Phase 3
~2670

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
56,924 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
31 Previous Clinical Trials
5,714 Total Patients Enrolled
~85 spots leftby Sep 2025
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