Ruxolitinib XR vs IR for Healthy Participants

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants

Eligibility Criteria

This trial is for healthy adults aged 18-55 with no significant clinical findings. Participants must be able to swallow pills, have a BMI of 18.0-32.0, and agree to avoid pregnancy or fathering children. Women past childbearing age or men who take precautions against fathering are eligible.

Inclusion Criteria

I am between 18 and 55 years old.

Participant Groups

The study aims to compare the bioequivalence of two forms of Ruxolitinib: an extended-release (XR) tablet and an immediate-release (IR) tablet, both taken orally by healthy participants.

4Treatment groups

Experimental Treatment

Group I: Period 2: Dose Treatment BExperimental Treatment1 Intervention

Ruxolitinib XR will be administered at protocol defined dose.

Group II: Period 2: Dose Treatment AExperimental Treatment1 Intervention

Ruxolitinib IR will be administered at protocol defined dose.

Group III: Period 1: Dose Treatment BExperimental Treatment1 Intervention

Ruxolitinib XR will be administered at protocol defined dose.

Group IV: Period 1: Dose Treatment AExperimental Treatment1 Intervention

Ruxolitinib IR will be administered at protocol defined dose.

Ruxolitinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Jakafi for: