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Janus Kinase (JAK) Inhibitor

Cohort 1: Dose Treatment A 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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to day 55
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 55 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
INCB018424 pharmacokinetic (PK) in Plasma
Secondary outcome measures
Additional INCB018424 pharmacokinetic (PK) in Plasma
Number of participants with Treatment Emergent Adverse Events (TEAEs)

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.

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
365 Previous Clinical Trials
55,165 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
23 Previous Clinical Trials
5,048 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the patient cohort being observed in this clinical investigation?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this trial. The trial was first listed on March 27th, 2024, with the most recent update made on March 7th, 2024. A total of 12 individuals are sought from a single site to partake in this study."

Answered by AI

Are new patients still eligible to participate in this ongoing clinical trial?

"Affirmative. Information available on clinicaltrials.gov indicates that this investigation is currently seeking eligible participants. Initially shared on March 27, 2024, and subsequently updated on March 7, 2024, the trial aims to enroll a total of 12 patients at one designated site."

Answered by AI

Is the research study open to participants who are older than 30 years of age?

"Eligible candidates for this research study must be between 19 and 55 years old. Notably, there are 68 investigations focused on individuals under 18 years old, while 376 studies target those above the age of 65."

Answered by AI

Has the FDA granted approval for Cohort 1: Dose Treatment A?

"Given the preliminary nature of this Phase 1 trial, Cohort 1: Dose Treatment A has been rated a safety score of 1 by our team at Power."

Answered by AI

Who else is applying?

What site did they apply to?
Celerion, Inc
What portion of applicants met pre-screening criteria?
Met criteria
~16 spots leftby Apr 2025