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Janus Kinase (JAK) Inhibitor
Cohort 1: Dose Treatment B for Healthy Subjects
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 55
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to compare how well the extended-release Ruxolitinib tablets work compared to the immediate-release tablets when taken by mouth in healthy individuals."
Who is the study for?
This clinical trial is open to healthy individuals who meet specific health criteria. The exact inclusion and exclusion details are not provided, but typically participants should have no significant medical conditions and be within a certain age range.
What is being tested?
The study is testing the bioavailability (how well the drug enters circulation) of two forms of Ruxolitinib: an extended-release (XR) tablet versus an immediate-release (IR) tablet when taken orally by healthy people.
What are the potential side effects?
Since this trial involves healthy volunteers, side effects may include typical drug reactions such as nausea, headaches, dizziness or allergic reactions. Specific side effects for Ruxolitinib XR vs IR are not detailed here.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 55
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 55
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
INCB018424 pharmacokinetic (PK) in Plasma
Secondary study objectives
Additional INCB018424 pharmacokinetic (PK) in Plasma
Number of participants with Treatment Emergent Adverse Events (TEAEs)
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 2: Dose Treatment BExperimental Treatment1 Intervention
Ruxolitinib XR will be administered at protocol defined dose.
Group II: Cohort 2: Dose Treatment AExperimental Treatment1 Intervention
Ruxolitinib IR will be administered at protocol defined dose.
Group III: Cohort 1: Dose Treatment BExperimental Treatment1 Intervention
Ruxolitinib XR will be administered at protocol defined dose.
Group IV: Cohort 1: Dose Treatment AExperimental Treatment1 Intervention
Ruxolitinib IR will be administered at protocol defined dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib XR
2024
Completed Phase 1
~30
Ruxolitinib IR
2024
Completed Phase 1
~30
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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
63,787 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
12,029 Total Patients Enrolled
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