A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants.
Part of paid clinical trials in Lincoln, Nebraska.
- Sponsor
- Incyte Corporation
- Study ID
- NCT06310304
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Participants
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Ruxolitinib IR — DRUGTablet
- Ruxolitinib XR — DRUGTablet
Study Details
This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants.
Key Dates
- Start date
- Mar 26, 2024
- Status verified
- Jun 2024
- Primary completion
- Apr 16, 2024
- Completion
- May 15, 2024
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: Dose Treatment ARuxolitinib IR will be administered at protocol defined dose.
- Experimental: Cohort 1: Dose Treatment BRuxolitinib XR will be administered at protocol defined dose.
- Experimental: Cohort 2: Dose Treatment ARuxolitinib IR will be administered at protocol defined dose.
- Experimental: Cohort 2: Dose Treatment BRuxolitinib XR will be administered at protocol defined dose.
Primary Outcome Measure
INCB018424 pharmacokinetic (PK) in Plasma [ Time Frame: Up to Day 22 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Celerion, Inc | Lincoln | Nebraska | 68502 | - |
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