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Tyrosine Kinase Inhibitor

Povorcitinib for Healthy Subjects

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
Aged 18 to 55 years, inclusive, at the time of signing the ICF
Ability to swallow and retain oral medication
Must not have
Inability to undergo venipuncture
Active infectious disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 25 (cohorts 1, 3 and 4), up to day 22 (cohort 2)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how Povorcitinib affects the way the body processes Digoxin, Rosuvastatin, and Metformin when taken by mouth in healthy adults.

Who is the study for?
This clinical trial is for healthy adults. Specific eligibility criteria are not provided, but typically participants should have no significant health issues and be on no other medications that could affect the study results.
What is being tested?
The study is testing how Povorcitinib affects the body's handling of three drugs: Digoxin (used for heart problems), Rosuvastatin (for cholesterol), and Metformin (for diabetes) when taken by mouth in healthy people.
What are the potential side effects?
Since this trial involves healthy volunteers, side effects might include reactions to Povorcitinib or changes in how the body processes the other drugs, which could lead to unexpected levels of these medicines in the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 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 cannot have blood drawn from my veins.
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I do not have any active infections.
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I have or had a condition that affects how my body absorbs nutrients.
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I have received a blood transfusion.
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I have not received any live vaccines recently.
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I am currently taking medication that affects how drugs are processed in my body.
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I have a history of heart, brain, blood vessel diseases, or uncontrolled high blood pressure.
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I have had heart problems or symptoms.
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I have not consumed any foods or medications that are not allowed.
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I have had recent serious stomach or intestine problems or surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 25 (cohorts 1, 3 and 4), up to day 22 (cohort 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 25 (cohorts 1, 3 and 4), up to day 22 (cohort 2) 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 metformin
PK in plasma rosuvastatin
Pharmacokinetic (PK) in plasma digoxin
Secondary study objectives
Additional digoxin PK parameters in plasma
Additional metformin PK parameters in plasma
Additional rosuvastatin PK parameters in plasma
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: DoseExperimental Treatment2 Interventions
Probenecid and povorcitinib will be administered at protocol defined doses.
Group II: Cohort 3: DoseExperimental Treatment2 Interventions
Metformin and povorcitinib will be administered at protocol defined doses.
Group III: Cohort 2: DoseExperimental Treatment2 Interventions
Rosuvastatin and povorcitinib will be administered at protocol defined doses.
Group IV: Cohort 1: DoseExperimental Treatment2 Interventions
Digoxin and povorcitinib will be administered at protocol defined doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probenecid
2018
Completed Phase 4
~720
Povorcitinib
2024
Completed Phase 1
~170
Metformin
2006
Completed Phase 4
~2430
Rosuvastatin
2019
Completed Phase 4
~3150
Digoxin
2017
Completed Phase 4
~670

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
391 Previous Clinical Trials
63,763 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
11,981 Total Patients Enrolled
~0 spots leftby Nov 2024
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